This page shows what was measured, who it was measured in, and what that does not settle.
What Donanemab does in the body
Early Alzheimer disease, with treatment stopped once the plaque is cleared
Amyloid plaque contains a chemically altered version of the amyloid protein that exists nowhere else in the body. Donanemab recognises only that altered form, so it binds plaque and ignores the circulating protein. Immune cells in the brain then strip the plaque away. When scans show the plaque has gone, treatment stops, which no other Alzheimer drug does.
What happened in people
iADRS difference of 3.25 points on a 0-144 scale in the low/medium tau population, 2.92 in the combined population
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
The limit that matters most
That the headline iADRS figure describes everyone who would receive the drug; it is the low/medium tau population, 68% of those enrolled
Where it acts
Brain parenchyma and cerebral vasculature
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 1ADB65P1KK · read 2026-08-29
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.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 93 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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
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.
Change from baseline in iADRS at 76 weeks, in the low/medium tau population and in the combined population
✓ The study showed what it set out to show
Who was studied
TRAILBLAZER-ALZ 2 (NCT04437511)
How many people
1736
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Low/medium tau difference 3.25 (95% CI 1.88-4.62), P < 0.001; combined population difference 2.92; 23 of 24 gated outcomes significant
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Deaths considered treatment related occurred in the donanemab group, in the context of ARIA. Only 76% of randomised participants completed the trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion over approximately 30 minutes, once every four weeks
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
RNAWiki holds 1 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.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□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.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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 changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Donanemab
What a person takes: Intravenous infusion over approximately 30 minutes, once every four weeks.
The measurement behind this step
Titrated over the first infusions to a 1,400 mg maintenance dose every four weeks, with treatment stopped when amyloid PET confirms clearance.
Getting in
Monthly infusion with a slow titration
A half-hour drip once a month, starting at a lower dose for the first few months because raising the dose too fast increases the risk of brain swelling.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The recommended regimen titrates over the first three infusions before reaching the 1,400 mg maintenance dose every four weeks. The slower titration tested in Study 2 cut the ARIA-E rate from 24% to 16% at 12 months without evident loss of amyloid clearance.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
Reaching the cell
Crossing the blood-brain barrier at low efficiency
Only a tiny fraction of the antibody reaches the brain, which is why the doses are large and the infusions repeated.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
IgG central nervous system penetration is on the order of 0.1-0.3% of plasma concentration. This limitation, common to the whole class, sets the dose rather than any property of the target.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
What it acts on
Binding an epitope that exists only in plaque
It recognises a chemically modified form of the amyloid protein created only after the protein has already been deposited. Circulating amyloid is invisible to it.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Binds N-terminally truncated amyloid beta bearing a pyroglutamate at position 3, AbetaP3-42, generated by aminopeptidase truncation and glutaminyl cyclase cyclisation within deposited plaque. Full-length monomeric amyloid beta is not bound, which concentrates the entire antibody dose onto deposited material.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
The change it makes
Rapid microglial plaque removal, and ARIA as its by-product
The brain immune cells strip the tagged plaque away over months. Where plaque sits in vessel walls, the same process weakens them and lets fluid or blood leak out.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
FcgammaR-mediated microglial phagocytosis clears opsonised plaque. Clearance of cerebral amyloid angiopathy deposits transiently compromises vascular wall integrity, producing ARIA-E and ARIA-H. The speed of clearance correlates with the ARIA rate, which is why slower titration lowers it.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
What that does for a person
Plaque clears, treatment stops, decline continues more slowly
Most patients reach a negative amyloid scan within a year and stop treatment. Decline carries on at roughly seven-tenths of the untreated rate.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Amyloid falls below 11 to 25 centiloids in most patients by week 76. CDR-SB decline is slowed by 0.70 points, 29%, over the same period. Amyloid may re-accumulate after stopping, and no data exist beyond 76 weeks to say whether re-treatment is needed.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 12.1 days
Read from the label, which states: “The mean terminal half-life of donanemab-azbt is approximately 12.1 days.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
People with mild cognitive impairment or mild dementia due to Alzheimer disease with confirmed amyloid pathology, who can attend monthly infusions and repeated MRI and PET imaging.
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: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-30
On older people, the label states: “In Study 1, the age of patients exposed to KISUNLA ranged from 59 to 86 years, with a mean age of 73 years; 90% were 65 years and older, and 41% were 75 years and older.”
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no adequate data on KISUNLA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of donanemab-azbt in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-30
Where the result stopped carrying
The original dosing regimen produced ARIA-E in 24% of patients and was replaced by a slower titration that halved that rate
Effects were smaller in the high-tau third of the enrolled population, who have the most advanced pathology and the greatest need
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
Given by a clinician
❝ 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
Intravenous infusion over approximately 30 minutes, once every four weeks
✎ 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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S6.
No source is stored against this line.
What is in the pack
Titrated over the first infusions to a 1,400 mg maintenance dose every four weeks, with treatment stopped when amyloid PET confirms clearance.
✎ 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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Boxed warning for amyloid related imaging abnormalities, which can be fatal, and for higher incidence in ApoE e4 homozygotes. MRI before the second, third, fourth and seventh infusions is required. Infusion-related reactions are common and premedication is often used.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
ClinicalTrials.gov, TRAILBLAZER-ALZ 2 (NCT04437511) · a recorded source, not a stored snapshot
Drugs@FDA, KISUNLA BLA 761248, original approval 2 July 2024 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761248) · 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
Intravenous infusion over approximately 30 minutes, once every four weeks
✎ 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
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 71124-0045 · read 2026-08-29
They are sold as injection, solution and liquid, taken intravenous.
FDA National Drug Code directory · 71124-0045 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-29
Kisunla is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 350 mg/20 mL (17.5 mg/mL) clear to opalescent, colorless to slightly yellow to slightly brown solution in a single-dose vial., recorded as fda label in effect 2025-12-30 in the United States.
US prescribing information · 190352d4-ef62-4679-b4fa-e846e2766afa · read 2026-08-30
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.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Donanemab 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the headline iADRS figure describes everyone who would receive the drug; it is the low/medium tau population, 68% of those enrolled
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That stopping treatment after clearance is durable; the label states amyloid may re-accumulate and no data exist beyond 76 weeks
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a 0.70-point CDR-SB difference is a change a family would perceive; the minimal clinically important difference is not established at that magnitude
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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.
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.
Every line above can be traced to the study named beside it. Follow the link and read it.
TRAILBLAZER-ALZ 2: iADRS difference of 3.25 points and 23 of 24 gated outcomes significant
In plain words
In 1,736 people with early symptomatic Alzheimer disease, donanemab slowed decline on the trial primary scale by 3.25 points on a 144-point range in the low-tau group, and nearly every prespecified outcome favoured the drug.
What was measured
iADRS difference 3.25 (95% CI 1.88-4.62) on a 0-144 scale, P < 0.001
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled 18-month phase 3 trial at 277 sites in 8 countries, 860 to donanemab and 876 to placebo, with two prespecified analysis populations defined by tau PET. Least-squares mean iADRS change at 76 weeks was -6.02 versus -9.27 in the low/medium tau population, difference 3.25 (95% CI 1.88-4.62), P < 0.001; the combined population difference was 2.92. Of 24 gated outcomes, 23 were statistically significant. Statistical alpha was split, 0.04 to the low/medium tau population and 0.01 to the combined population.
Written into the record, not signed off as a reviewed claim
CDR-SB slowed by 0.70 points, or 29%, in the combined population
In plain words
On the same 18-point disability scale used for lecanemab, donanemab-treated patients declined by 1.72 points against 2.42 on placebo over 76 weeks.
What was measured
CDR-SB 1.72 versus 2.42, difference -0.70 (29% slowing), P < 0.0001
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
From the label, combined population, mixed model for repeated measures: adjusted mean CDR-SB change from baseline at week 76 was 1.72 on donanemab and 2.42 on placebo, a difference of -0.70 or 29% slowing, P < 0.0001, from mean baselines of 3.92 and 3.89. ADAS-Cog13 difference was -1.33 (20%, P = 0.0006) and ADCS-iADL difference 1.70 (28%, P = 0.0001).
Source
KISUNLA US Prescribing Information, Clinical Studies, Table 9
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Treatment stops when the plaque is gone, and 69% qualified to stop by week 76
In plain words
Unlike every other Alzheimer drug, donanemab has a finish line built into the protocol. Patients whose amyloid scans fell below threshold were switched to placebo, and by 76 weeks most had.
What was measured
17%, 47% and 69% of patients eligible to stop treatment at weeks 24, 52 and 76
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Patients were eligible to switch to placebo if amyloid was below 11 centiloids on a single PET scan or 11 to under 25 centiloids on two consecutive scans. The proportion eligible to switch was 17% at week 24, 47% at week 52 and 69% at week 76. This design makes the treatment a finite course rather than an indefinite one. The label states plainly that amyloid PET values may rise again after donanemab is stopped, and that there are no data beyond 76 weeks to guide whether further dosing is needed.
Source
KISUNLA US Prescribing Information, Clinical Studies
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ARIA in 36% of patients, with brain swelling in 24% and fatal haemorrhage reported
In plain words
More than one patient in three developed amyloid-related imaging abnormalities, nearly one in four had brain swelling and nearly one in three had microbleeding. Fatal brain haemorrhages have occurred.
What was measured
ARIA 36%, ARIA-E 24%, ARIA-H 31% versus 14%, 2%, 13% on placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
From the label, Study 1 with the original dosing regimen: ARIA of any kind in 36%, ARIA-E in 24% and ARIA-H in 31% of donanemab patients, against 14%, 2% and 13% on placebo. Symptomatic ARIA-E in 6%, resolving clinically in about 85%. Intracerebral haemorrhage larger than 1 cm in 0.5% versus 0.2%, with fatal events observed. In ApoE e4 homozygotes ARIA occurred in 55% versus 22% on placebo. A modified titration regimen tested in Study 2 reduced ARIA-E to 16% at 12 months and is now the recommended dosing.
Source
KISUNLA US Prescribing Information, boxed warning and Warnings and Precautions 5.1
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The tau-stratified design makes the headline number the best of two populations
In plain words
The trial defined two analysis populations by how much tau protein each patient had, and gave most of its statistical budget to the low-tau group where the effect was larger. The number most often quoted comes from that group, not from everybody enrolled.
What was measured
That the headline efficacy figure applies to everyone who would receive the drug in practice
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Statistical alpha was allocated 0.04 to the low/medium tau population and 0.01 to the combined population. The headline iADRS difference of 3.25 is the low/medium tau figure; the combined population figure is 2.92. This is a prespecified and legitimate design, and it also means the widely quoted result describes 68% of enrolled patients rather than all of them. The high-tau third, who have more advanced pathology, showed smaller effects.
Source
Sims et al., JAMA 2023, prespecified statistical analysis plan
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Amyloid removal is now measurably necessary but demonstrably not sufficient
In plain words
Donanemab removes plaque faster and more completely than any previous antibody. Decline still continues at roughly seven-tenths of the placebo rate. Whatever else drives Alzheimer disease, it is not fully stopped by clearing amyloid.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Amyloid clearance below the PET positivity threshold in most patients within a year produced a 29% slowing on CDR-SB and a 20% slowing on ADAS-Cog13. The tau-stratified design itself encodes the shift: tau burden predicted treatment effect, which places the amyloid cascade upstream of a tau-driven process that continues after amyloid is gone. The field has moved from testing whether amyloid matters to asking how much of the remaining decline is tau, inflammation or synaptic loss.
Source
Tau stratification results in Sims et al., JAMA 2023, and the KISUNLA label Clinical Studies section
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
1ADB65P1KK
CAS registry number
1931944-80-7
WHO international nonproprietary name list entry
10922
EMA substance identifier
300000005929
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How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
The earliest marketing start date recorded for a listed product is 20220316.
FDA National Drug Code directory · 71124-0045 · read 2026-08-29
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An antibody against plaque-specific pyroglutamate amyloid beta that slowed CDR-SB decline by 0.70 points over 76 weeks in 1,736 patients, cleared enough plaque to stop treatment in 69% of them by week 76, and caused brain swelling in 24%.
Recorded evidence blocks (6)
Q2
What did Donanemab's largest trial (6250 people) and its longest (8.4 years) measure?
6250 people in Donanemab's largest registered study, 8.4 years in its longest registered window, measuring Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6. ClinicalTrials.gov · 2026-09-01
8 phase3, 5 phase2, 3 phase1, 1 na or unstated, 1 phase4; NCT04437511; 2028-11; no ageing endpoint recorded. Last human test completed 2024, NCT04640077.
Interpretation These counts include studies where Donanemab 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
phase3
8
phase2
5
phase1
3
na or unstated
1
phase4
1
Last recorded human testNCT04640077
2024-02-27
recorded 2026-09-01 · last checked 2026-09-04
Q3
Donanemab was tested only in human — what did it show?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4,… — the recorded outcome words.
Show the evidence
humanNCT05567159
biomarker; Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.; 17
recorded 2026-09-01 · last checked 2026-09-04
Q4
Donanemab's half-life is 12.1 days — which schedules were studied?
12.1 days, the half-life Donanemab's label states. openfda-label · 190352d4-ef62-4679-b4fa-e846e2766afa · 2026-08-30
Show the evidence
half life
12.1 days; The mean terminal half-life of donanemab-azbt is approximately 12.1 days.
metabolism
Donanemab-azbt is degraded by proteolytic enzymes and is not expected to undergo renal elimination or metabolism by hepatic enzymes.
recorded 2026-08-30 · last checked 2026-09-04
Q5
Which of Donanemab's 11 ongoing trials reports first?
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population); Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0]); latest 2033-02
Show the evidence
Trial
NCT04437511
"A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)"; n 1736; "Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)"; 2028-11
NCT05026866
"A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)"; n 2996; "Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0])"; 2027-11
NCT05508789
"A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)"; n 1500; "Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)"; 2028-07
NCT05738486
"A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)"; n 1175; "Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)"; 2027-05
NCT06566170
"A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease"; n 6250; "Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])"; 2033-02
NCT06911944
"Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation"; n 60; "Change from baseline on brain amyloid levels"; 2028-12-31
5 further recorded trials
NCT06996730
"A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease"; n 240; "Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint"; 2030-06-01
NCT07167966
"Alzheimer's Tau Platform: Regimen A - AADvac1"; n 450; "Reduction of brain tau deposition as measured by tau positron emission tomography (PET)"; 2028-08-31
NCT07571161
"Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease"; n 140; "Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)"; 2030-04
NCT07589595
"A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)"; n 350; "Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)"; 2028-08
NCT07602582
"A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT)."; n 550; "Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)"; 2029-09
recorded 2026-09-01 · last checked 2026-09-04
Q6
At the median, Donanemab's trials enrolled 272 people — anything larger?
Median enrolment
272
Largest enrolment
6250
Registered trials counted
17
Q7
Was Donanemab studied with exercise?
exercise is named in Donanemab's label sentences: "Although melatonin and aerobic exercise for a short time were significantly more effective than donanemab, lecanemab, aducanumab and placebo in the primary analysis, there was significant heterogeneity." openfda-label+europepmc · 2024-01-01
1 recorded statement; exercise
Show the evidence
exercise
Although melatonin and aerobic exercise for a short time were significantly more effective than donanemab, lecanemab, aducanumab and placebo in the primary analysis, there was significant heterogeneity.
recorded 2024-01-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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