Alzheimer DiseasePhase 4NCT07838155
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease
A Phase 4 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 12 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesIndia
- Study dates
- Nov 2026to Sep 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gradual and progressive change in memory function reported by the participant or informant for greater than or equal to (≥) 6 months.
- Clinical diagnosis of mild cognitive impairment due to Alzheimer's Disease (AD) or mild Alzheimer's dementia.
- Evidence of amyloid pathology confirmed by plasma phosphorylated tau217 (P-tau217) levels.
- A Mini Mental State Examination (MMSE) score of 20 to 28 (inclusive).
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant, and will accompany the participant to study visits or be available by telephone at designated times.
Who cannot join
- Have significant neurological disease affecting the central nervous system other than AD.
- Have a condition that in the investigator's opinion could interfere with the analyses of this study.
- Have a life expectancy of less than 24 months.
- Have a presence or history of malignant neoplasms within the past 5 years.
- Are actively suicidal.
- Have a diagnosis of alcohol or drug use disorder, except tobacco use disorder.
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- Have a history of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity.
- Have previously received or are currently receiving treatment with a passive antiamyloid immunotherapy.
- Have received active immunization against amyloid-beta (Aβ) in any other study.
- Have known allergies to donanemab, related compounds, or any components of the formulation.
- Have any clinically important abnormality at screening.
- Screening magnetic resonance imaging (MRI) that shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
- Have an MRI demonstrating presence of amyloid-related imaging abnormalities that show cerebral edema (ARIA-E), greater than (>) 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage, or severe white matter disease.
- Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or a cardiac pacemaker.
- Poor venous access.
- Alanine aminotransferase (ALT) ≥2.5× upper limit of normal (ULN) of the performing laboratory, aspartate aminotransferase (AST) ≥2.5× ULN, total bilirubin (TBL) ≥1.5× ULN, or alkaline phosphatase (ALP) ≥2× ULN at screening.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
12 sites in 1 country
India12 sites
Manipal Hospital
Bangalore, 560017
Pramod Krishnan
NIMHANS
Bangalore, 560029
Faheem Arshad
Aster CMI Hospital
Bangalore, 560092
Lokesh B
Yashoda Hospital Somajiguda, Hyderabad
Hyderabad, 500082
Jaydip Ray Chaudhuri
Bangur Institute of Neurosciences (BIN) and Institute of Post Graduate Medical Education and Research (IPGME&R)
Kolkata, 700025
Atanu Biswas
Apollo Multispeciality Hospitals limited
Kolkata, 700054
Amitabha Ghosh
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, 400053
Anu Aggarwal
Institute of Human Behaviour and Allied Sciences
New Delhi, 110025
Suman Kushwah
All India Institute of Medical Sciences (AIIMS), New Delhi
New Delhi, 110029
Manjari Tripathi
Indraprastha Apollo Hospital
New Delhi, 110076
PN Renjen
Apollo Speciality Hospital - Teynampet
Tamil Nadu, 600006
Srikanth Srinivasan
Christian Medical College Vellore
Vellore, 632 004
A T Prabhakar (Dr. Ajith Sivadasan)
About this study
Official title: A Phase 4, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Tolerability of Donanemab in Indian Participants With Early Symptomatic Alzheimer's Disease
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.
- Conditions
- Alzheimer Disease
- Being tested
- Donanemab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called LY3002813
Donanemab administered IV
| Study group | Role | What they receive |
|---|---|---|
| Donanemab | Experimental | Donanemab administered intravenously (IV) Receives: Drug: Donanemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)
Measured: Baseline Up to Week 24, 52
Frequency and Severity of Infusion-Related Reactions
Measured: Through Week 52
Secondary outcomes (2)
Change from Baseline in Mini Mental State Examination (MMSE) Score
Measured: Baseline through Week 76
Change from Baseline in Plasma Phosphorylated Tau217 (P-tau217)
Measured: Baseline through Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838155
- Sponsor's protocol ID
- 27847
- Other IDs
- I5T-IN-AACX
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.