This page shows what was measured, who it was measured in, and what that does not settle.
What Donepezil does in the body
Dementia of the Alzheimer's type
From the FDA-approved label: Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
Its recorded molecular formula is C24H29NO3HCl, weighing 415.96.
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 90 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer5 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Mood
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Focus
cognitive function; global cognitive performance; cognitive instrumental activities of daily living; cognitive performance; alzheimer s disease assessment scale cognitive subscale; cognitive function measured the standardised mmse
Mood
recurrence of major depression
Pain
visual analog scale for pain
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
5 registered performance measure of this kind.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
survival free of discontinuation or alternative prevention drug (migraine trial)
✗ The study did not show it
Who was studied
NCT02670161
How many people
3300
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
PSCI incidence
✗ The study did not show it
Who was studied
NCT05976152
How many people
3200
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48
✗ The study did not show it
Who was studied
NCT00348309
How many people
1496
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort
✗ The study did not show it
Who was studied
NCT00348140
How many people
1468
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change From Baseline to Week 24 in SIB Total Score
✗ The study did not show it
Who was studied
NCT00478205
How many people
1467
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
✗ The study did not show it
Who was studied
NCT02079246
How many people
1463
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.6 registered measures of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.6 registered measures of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.4 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Drosophila (fruit fly), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
cohen mansfield agitation inventory
clinical global impression
visual analog scale for pain
neuropsychiatric inventory
Measured
Things only a test, a scale or a device shows.
cerebral blood flow
Meaningful
Things that change how a life goes, not only a number.
cognitive function
global cognitive performance
cognitive instrumental activities of daily living
cognitive performance
cognitive function measured the standardised mmse
functional independence measure
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (29)
safety
adas cog
recurrence of major depression
safety assessments
language function
communication
panss
incidence of delirium
physical function
cerad k
psychomotor vigilance test
adverse events
mini mental state examination total
alzheimer s disease assessment scale cognitive subscale
pk variables
rate of change of hippocampal volume slope
treatment emergent adverse events
contingency naming test performance
mini mental state examination
discontinuation rates
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
On older people, the label states: “Alzheimer's disease is a disorder occurring primarily in individuals over 55 years of age.”
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women.”
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production.”
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, orally disintegrating, capsule, extended release, system, given by the oral, transdermal route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Donepezil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4536 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
fall — 702 reaction mentions
bradycardia — 694 reaction mentions
confusional state — 583 reaction mentions
vomiting — 541 reaction mentions
syncope — 486 reaction mentions
drug interaction — 392 reaction mentions
agitation — 313 reaction mentions
loss of consciousness — 277 reaction mentions
hallucination — 274 reaction mentions
somnolence — 274 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
120 products list this as an active ingredient in the United States drug directory. 102 of them contain it and nothing else.
FDA National Drug Code directory · 72162-2137 · read 2026-08-29
They are sold as capsule, capsule, extended release, powder, tablet, tablet, film coated and tablet, orally disintegrating, taken oral.
FDA National Drug Code directory · 72162-2137 · read 2026-08-29
The regulator's established pharmacologic class for it is cholinesterase inhibitor [epc] and cholinesterase inhibitors [moa].
FDA National Drug Code directory · 72162-2137 · read 2026-08-29
58 published labels name it as an active ingredient. 52 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-29
1 marketed supplement label lists this ingredient, classed as fat/fatty acid.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
donepezil hydrochloride is oral at 3 DOSAGE FORMS AND STRENGTHS Donepezil hydrochloride is supplied as film-coated, round tablets containing 5 mg, 10 mg of donepezil hydrochloride, USP., recorded as fda label in effect 2023-02-06 in the United States.
US prescribing information · 5d46ef3c-0dee-4389-a2d5-997ea8342817 · read 2026-08-30
Recorded price in US: 0.04349–0.72915 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 62 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Donepezil studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Donepezil are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
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58 approved applications cover products containing this substance. The earliest was NDA020690, approved 19961125 to EISAI INC.
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6 questions this page could not answer
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Recorded evidence blocks (14)
Q1
What did Donepezil's largest trial (10238 people) and its longest (15 years) measure?
10238 people in Donepezil's largest registered study, 15 years in its longest registered window, measuring Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with… ClinicalTrials.gov · 2026-09-01
65 phase2, 61 phase1, 55 phase4, 36 phase3, 21 na, 14 na or unstated, 6 early phase1; NCT03073876; 2021-01-13; no ageing endpoint recorded. Last human test completed 2026, NCT06903910.
Interpretation These counts include studies where Donepezil was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
65
phase1
61
phase4
55
phase3
36
na
21
na or unstated
14
2 more recorded rows
early phase1
6
Last recorded human testNCT06903910
2026-01-31
recorded 2026-09-01 · last checked 2026-09-04
Q2
From Drosophila to human: where has Donepezil shown lifespan?
Interpretation Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with… — the recorded outcome words.
Show the evidence
Drosophila
mechanism-only
mouse
lifespan
rat
mechanism-only
humanNCT00006349
healthspan; Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo; 252
recorded 2026-09-01 · last checked 2026-09-04
Q3
30 of Donepezil's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (3), futility/efficacy (1), accrual/recruitment (10), funding/business (3) and other (13): Donepezil's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Study terminated/withdrawn"; 30 of 252 registered studies
Show the evidence
Trial
NCT00062972
withdrawn; "Study terminated/withdrawn"
NCT00165750
terminated; "Lack of patients to enroll."
NCT00174382
terminated; "See Detailed Description"
NCT00206947
terminated; "No more funding"
NCT00352664
terminated; "Low patient accrual"
NCT00369603
terminated; "Reduced access to AchEI medication-naive mild AD patients."
14 further recorded trials
NCT00602680
terminated; "Insufficient expected benefit risk"
NCT00619983
terminated; "Study terminated due to low enrollment"
NCT00675025
terminated; "Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns."
NCT00711204
withdrawn; "No patients were enrolled in the study."
NCT00713765
terminated; "Ended prematurely - The trial never commenced."
NCT00754013
terminated; "Sufficient evidence of efficacy not met."
NCT00754052
terminated; "Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns."
NCT00843115
terminated; "See Detailed Description."
NCT00895895
terminated; "See termination reason in detailed description."
NCT01014858
terminated; "Due to low recruitment"
NCT01082965
terminated; "The study was terminated because of slow enrollment. The decision to terminate the trial was not based on any safety or efficacy concerns."
NCT01125683
terminated; "Poor recruitment."
NCT01362686
terminated; "Low study accrual caused the study to be ended early."
NCT01442766
withdrawn; "No financial support"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Donepezil used donepezil (5-10 mg/day) — over how long?
U-shaped in human: "At a high dose (2.0 mg/kg), donepezil tended to promote depression-like behavior, suggesting a u-shaped dose-response curve for FST immobility." Europe PMC · dose-response search · 2025-12-31
5 recorded sentences naming Donepezil; u-shaped, dose-response
Show the evidence
u-shaped
PMID 33910028
"At a high dose (2.0 mg/kg), donepezil tended to promote depression-like behavior, suggesting a u-shaped dose-response curve for FST immobility."
PMID 32712627
"These data support a novel antidepressant-like role for donepezil at lower doses as part of an overall u-shaped dose-response curve."
dose-response
"The demonstrated dose-response, dosing-related superiority over 15 mg/kg donepezil, and lack of overt adverse effects support its translational potential as a safe, plant-based adjunct to excitotoxic diseases and toxin-exposed populations."
"The demonstrated dose-response, showed numerically greater effects over 15 mg/kg donepezil, although direct superiority comparisons were not pre-specified."
PMID 33519395
"Our data therefore suggest a Janus-faced dose-response curve for donepezil in depression-related behavior."
recorded 2025-12-31 · last checked 2026-09-04
Q6
Could one person measure Donepezil's effect on cognitive function?
Cognitive function: measured in Donepezil's trials.
Interpretation cognitive function is the recorded endpoint.
Show the evidence
biomarkers
cognitive function; 2026-09-01
cohen mansfield agitation inventory; 2026-09-01
safety; 2026-09-01
adas cog; 2026-09-01
global cognitive performance; 2026-09-01
cognitive instrumental activities of daily living; 2026-09-01
14 more recorded rows
biomarkers
recurrence of major depression; 2026-09-01
biomarkers
safety assessments; 2026-09-01
biomarkers
clinical global impression; 2026-09-01
biomarkers
language function; 2026-09-01
biomarkers
communication; 2026-09-01
biomarkers
panss; 2026-09-01
biomarkers
incidence of delirium; 2026-09-01
biomarkers
physical function; 2026-09-01
biomarkers
cerad k; 2026-09-01
biomarkers
psychomotor vigilance test; 2026-09-01
biomarkers
adverse events; 2026-09-01
biomarkers
mini mental state examination total; 2026-09-01
biomarkers
cognitive performance; 2026-09-01
biomarkers
visual analog scale for pain; 2026-09-01
human trials at or under30
71
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT00062972; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adas cog, adverse events and alzheimer s disease assessment scale cognitive subscale did Donepezil's trials measure?
adas cog, adverse events and alzheimer s disease assessment scale cognitive subscale lead 40 outcome terms across Donepezil's trials. ClinicalTrials.gov · 2026-09-01
Interpretation adas cog, global cognitive performance, cognitive instrumental activities of daily living, recurrence of major depression, safety assessments and clinical global impression follow.
Show the evidence
cognitive function
1
cohen mansfield agitation inventory
1
safety
1
adas cog
1
global cognitive performance
1
cognitive instrumental activities of daily living
1
14 more recorded rows
recurrence of major depression
1
safety assessments
1
clinical global impression
1
language function
1
communication
1
panss
1
incidence of delirium
1
physical function
1
cerad k
1
psychomotor vigilance test
1
adverse events
1
mini mental state examination total
1
cognitive performance
1
visual analog scale for pain
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Donepezil's 13 ongoing trials reports first?
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog); Difference of change in the MMSE score; latest 2030-05-06
Show the evidence
Trial
NCT03810794
"Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease"; n 180; "Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)"; 2026-12-30
NCT04661280
"Donepezil Versus Non-drug Treatment in Alzheimer's Disease."; n 240; "Difference of change in the MMSE score"; 2026-08
NCT05345509
"A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003."; n 62; "AUClast of IVL3003"; 2025-11-13
NCT05438264
"Effect of Donepezil on Speech Recognition in Cochlear Implant Users"; n 50; "Postoperative monosyllabic word recognition"; 2026-09-01
NCT05592678
"δ in Dementia Clinical Trials"; n 200; "dTEL change"; 2028-11-30
NCT05801380
"Monitoring Drug Efficacy in Patients with Alzheimer's Disease"; n 60; "Change in gene signatures"; 2026-02-14
7 further recorded trials
NCT06041789
"Effect of Acetylcholinesterase Inhibitors on Bone Metabolism"; n 45; "Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)"; 2026-11
NCT06417086
"Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers"; n 176; "Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)"; 2026-11-30
NCT06518941
"An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa"; n 10; "Side Effects Form"; 2028-12
NCT06687993
"Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial"; n 147; "Effect on Body Mass Index in adult women suffering from anorexia nervosa"; 2030-05
NCT06828289
"Rivastigmine Mini-Tablet for Alzheimer's Disease"; n 1000; "Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)"; 2026-12-31
NCT07066826
"Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type"; n 720; "ADAS-Cog11"; 2028-08-15
NCT07768592
"A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)"; n 32; "Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 Days"; 2030-05-06
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 104 trials of Donepezil posted no result?
Posted no result
104 of 104 completed trials
Registrations
NCT00018278, NCT00467766, NCT00000173, NCT00006399, NCT00042172 and NCT00630851, and 98 more
Completion dates
oldest 2001-09; newest 2024-04-01
Show the evidence
Trial
NCT00018278
2001-09
NCT00467766
2003-06
NCT00000173
2004-01
NCT00006399
2004-03
NCT00042172
2004-09
NCT00630851
2004-10
14 further recorded trials
NCT00480870
2005-01
NCT00030979
2005-03
NCT00196690
2005-03
NCT00165815
2005-07
NCT00188812
2005-08
NCT00096473
2005-09
NCT00165737
2006-06
NCT00165724
2006-12-31
NCT00006349
2007-01
NCT00103948
2007-02
NCT00293176
2007-03
NCT01146509
2007-03
NCT00182845
2007-04
NCT00182884
2007-04
Q10
At the median, Donepezil's trials enrolled 60 people — anything larger?
Median enrolment
60
Largest enrolment
10238
Registered trials counted
245
Q11
What do 4536 spontaneous reports say about Donepezil — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Donepezil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4536 reaction mentions were counted: fall 702; bradycardia 694; confusional state 583; vomiting 541. open-targets-adr · CHEMBL1678 · 2026-06-24
Show the evidence
fall
702
bradycardia
694
confusional state
583
vomiting
541
syncope
486
drug interaction
392
4 more recorded rows
agitation
313
loss of consciousness
277
hallucination
274
somnolence
274
recorded 2026-06-24 · last checked 2026-09-04
Q12
Donepezil and CYP2D6, CYP2B6 and CYP2C19: shared by which compounds?
CYP2D6, CYP2B6 and CYP2C19 appear in Donepezil's recorded interaction sentences, 8 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2B6pharmacokinetics
Based on in vitro studies, donepezil shows little or no evidence of direct inhibition of CYP2B6, CYP2C8 and CYP2C19 at clinically relevant concentrations.
CYP2C19pharmacokinetics
Based on in vitro studies, donepezil shows little or no evidence of direct inhibition of CYP2B6, CYP2C8 and CYP2C19 at clinically relevant concentrations.
CYP2C8pharmacokinetics
Based on in vitro studies, donepezil shows little or no evidence of direct inhibition of CYP2B6, CYP2C8 and CYP2C19 at clinically relevant concentrations.
CYP2D6
pharmacokinetics
Examination of the effect of CYP2D6 genotype in Alzheimer's patients showed differences in clearance values among CYP2D6 genotype subgroups.
pharmacokinetics
Drug Interactions: Effect of Donepezil Hydrochloride on the Metabolism of Other Drugs No in vivo clinical trials have investigated the effect of donepezil hydrochloride on the clearance of drugs metabolized by CYP 3A4 (e.g., cisapride, terfenadine) or by CYP 2D6 (e.g., imipramine).
pharmacokinetics
Population pharmacokinetic analysis showed that in the presence of concomitant CYP2D6 inhibitors donepezil AUC was increased by approximately 17% to 20% in Alzheimer’s disease patients taking donepezil hydrochloride 10 and 23 mg.
pharmacokinetics
This represented an average effect of weak, moderate, and strong CYP2D6 inhibitors.
CYP3A4pharmacokinetics
Drug Interactions: Effect of Donepezil Hydrochloride on the Metabolism of Other Drugs No in vivo clinical trials have investigated the effect of donepezil hydrochloride on the clearance of drugs metabolized by CYP 3A4 (e.g., cisapride, terfenadine) or by CYP 2D6 (e.g., imipramine).
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Donepezil studied with fasting and exercise?
fasting and exercise are named in Donepezil's label sentences: "In MDX-PK-104 study, fasting participants (N = 38) received co-administered memantine ER and donepezil or the FDC." openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
In MDX-PK-104 study, fasting participants (N = 38) received co-administered memantine ER and donepezil or the FDC.
exercise
However, randomised controlled trials (RCTs) of exercise have shown conflicting findings and it is unclear if positive outcomes are comparable to a commonly used cholinesterase inhibitor, donepezil.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Donepezil and AMPK?
"At the molecular level, both donepezil and combination therapy activated PI3K-AKT and AMPK signaling and increased inhibitory phosphorylation of GSK-3β compared with untreated 5xFAD mice; no significant difference was observed between the two treatment groups." — where Donepezil and AMPK appear together. Europe PMC · pathway abstract search · 2026-08-01
"At the molecular level, both donepezil and combination therapy activated PI3K-AKT and AMPK signaling and increased inhibitory phosphorylation of GSK-3β compared with untreated 5xFAD mice; no significant difference was observed between the two treatment groups."
PMID 39580762
"Knockdown of FGF21 or AMPK via siRNA reversed the effects of donepezil on insulin signaling and inflammation in cultured myocytes."
autophagy
PMID 42660828
"Methods Network pharmacology was employed to predict YA3D3 targets.Total antioxidant capacity and hydroxyl free radical scavenging activity were measured <i>in vitro</i>.BV2 microglial cells were infected with short hairpin RNA （shRNA） lentivirus targeting ATG14 （designated as sh-ATG14） and then treated with 0.5 mg/mL of either water-extract （YA3D3-HF） or fermented （YA3D3-MHF） preparation for 24…"
PMID 42660828
"Results Network pharmacology indicated significant enrichment of YA3D3 targets in autophagy and phosphatidylinositol 3-kinase/protein kinase B signaling pathways.YA3D3-MHF showed stronger antioxidant activity than YA3D3-HF <i>in vitro</i> （<i>P</i><0.001）.In BV2 cells，both preparations reversed ATG14 knock-down-induced down-regulation in the expression of ATG14 and ATG16L1，with YA3D3-MHF being…"
AMPKPMID 41048705
"The docking results indicate that pseudoberberine, beta-lapachone, and donepezil from predicted AMPK activators exhibit stronger AMPK binding affinities (-8.205, -7.585, and -7.484 kcal/mol, respectively) than metformin (-5.387 kcal/mol), emphasizing the model's capability to identify novel AMPK activators."
autophagyPMID 39063593
"Here, we used in vitro and in vivo models to investigate the effect of Donepezil-an acetylcholinesterase (AChE) inhibitor-on cognitive impairment in the acute period following injury, while focusing on neuroinflammation and autophagy- and mitophagy-related markers."
sirtuin
PMID 35286233
"The OGD/R-induced cell were added with different doses of donepezil with or without Sirtuin-1 (SIRT1) inhibitor EX527."
PMID 35286233
"However, pretreatment with the SIRT1 inhibitor EX527 reversed the protective effect of donepezil on OGD/R-induced HBMECs."
PMID 35286233
"In summary, Donepezil ameliorates OGD/R-induced brain microvascular endothelial cell dysfunction via the SIRT1/FOXO3a/NF-κB pathways."
recorded 2026-08-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 11 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.