Donanemab Safety Study in Early Alzheimer's Disease
Tests donanemab's safety and side effects in people with early Alzheimer's symptoms.
Plain-language title generated from the registry record
Registry title: A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease
Key facts
- Where
- Bangalore, Hyderabad, Kolkata, Mumbai, New Delhi, Tamil Nadu, and Vellore, IndiaSee the 12 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 85 years old?
Source: NCT07838155, who can take part
Where in India
- Aster CMI HospitalBangalore, IndiaNo longer taking part
- Manipal HospitalBangalore, IndiaNo longer taking part
- NIMHANSBangalore, IndiaNo longer taking part
- Yashoda Hospital Somajiguda, HyderabadHyderabad, IndiaNo longer taking part
- Apollo Multispeciality Hospitals limitedKolkata, IndiaNo longer taking part
- Bangur Institute of Neurosciences (BIN) and Institute of Post Graduate Medical Education and Research (IPGME&R)Kolkata, IndiaNo longer taking part
- Kokilaben Dhirubhai Ambani Hospital & Medical Research InstituteMumbai, IndiaNo longer taking part
- All India Institute of Medical Sciences (AIIMS), New DelhiNew Delhi, IndiaNo longer taking part
- Indraprastha Apollo HospitalNew Delhi, IndiaNo longer taking part
- Institute of Human Behaviour and Allied SciencesNew Delhi, IndiaNo longer taking part
- Apollo Speciality Hospital - TeynampetTamil Nadu, IndiaNo longer taking part
- Christian Medical College VelloreVellore, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07838155
- Record updated
- 15 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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 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; 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; Have a life expectancy of less than 24 months; Are actively suicidal; Have any clinically important abnormality at screening; Poor venous access.