NCT07838155Not yet recruitingPhase 4
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT07838155
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From Nov 2026 to the primary completion date, Sept 2030
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 presence or history of malignant neoplasms within the past 5 years.
- Have a diagnosis of alcohol or drug use disorder, except tobacco use disorder.
- Have a history of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity.
- Have known allergies to donanemab, related compounds, or any components of the formulation.
- 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.
Lab values
- 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.
Other
- Have a life expectancy of less than 24 months.
- Are actively suicidal.
- Have any clinically important abnormality at screening.
- Poor venous access.
Who the study is looking for
- 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.
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aster CMI Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| NIMHANS Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Manipal Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Yashoda Hospital Somajiguda, Hyderabad Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Apollo Multispeciality Hospitals limited Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Bangur Institute of Neurosciences (BIN) and Institute of Post Graduate Medical Education and Research (IPGME&R) Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS), New Delhi Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Indraprastha Apollo Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Institute of Human Behaviour and Allied Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Apollo Speciality Hospital - Teynampet Coordinator of this site? Confirm its status | Tamil Nadu | India | Unknown status |
| Christian Medical College Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.