A Phase 4 interventional study of Donanemab in Alzheimer Disease, sponsored by Eli Lilly and Company. Not yet recruiting at 12 sites in India. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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Among 15 studies testing donanemab in Alzheimer Disease — 7 open to participants now, 10 under way, 6 of them phase 3. donanemab · Alzheimer Disease.
Among the 15 studies testing donanemab in Alzheimer Disease, this one is the 15th largest by planned enrollment, is one of 7 that started in 2026, is one of 2 in phase 4, and was the 15th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →7 of the 15 studies testing donanemab in Alzheimer Disease are open now, in 8 countries. Recruiting first, the newest first:
Banner Health · Sites in Colombia
Ages 25–65 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Puerto Rico
Ages 55+
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Eli Lilly and Company · Sites in China
Ages 55–80
Paul S. Aisen · Sites in United States
Ages 50–80
By country, each count listing its studies:
donanemab: first FDA approval 2024 (KISUNLA), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 7 · Phase 4 2
First in 2013; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 50 is below the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 240 across the 15 interventional studies. Of the 5 that completed or were terminated, 5 (100%) have results posted.
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12 of 15 have an industry lead sponsor. The 4 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
99 studies in Alzheimer Disease by Eli Lilly and Company: 13 open now, 19 under way, 8 of them phase 3. Of 79 finished, 61 (77%) have results posted.
Among the 99 studies in Alzheimer Disease by Eli Lilly and Company, this one is the 61st largest by planned enrollment of the 95 interventional ones that give a count, is one of 8 that started in 2026, is one of 5 in phase 4, reaches primary completion later than 16 of the 18 other live ones, and was the 98th registered.
Eli Lilly and Company’s Alzheimer Disease studies by the year they started, since 2002.
1 of the studies testing donanemab in Alzheimer Disease that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05026866Phase 3Eli Lilly and CompanyA Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | 2027-11 |
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Among the 15 studies testing donanemab in Alzheimer Disease, from their registry updates:
Among Eli Lilly and Company’s 99 in Alzheimer Disease:
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The main purpose of this study is to assess how well Donanemab is tolerated and what side effects may occur in Indian participants with early symptoms of Alzheimer's Disease (AD). For each participant, the study will last up to approximately 84 weeks and will include visits every 4 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Donanemab administered intravenously (IV)
Drug: Donanemab
Donanemab administered IV
Also known as: LY3002813
Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)
Time frame: Baseline Up to Week 24, 52
Frequency and Severity of Infusion-Related Reactions
Time frame: Through Week 52
Change from Baseline in Mini Mental State Examination (MMSE) Score
Time frame: Baseline through Week 76
Change from Baseline in Plasma Phosphorylated Tau217 (P-tau217)
Time frame: Baseline through Week 76
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2030, 46 months later.
Of 41 phase 4 interventional studies under Alzheimer Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 67. This study's planned 46 months is close to that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: start Oct 2026 → Nov 2026, primary completion Jul 2030 → Sep 2030 and completion Jul 2030 → Sep 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donanemab