Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aster CMI Hospital
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
NIMHANS
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
Manipal Hospital
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
Yashoda Hospital Somajiguda, Hyderabad
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Apollo Multispeciality Hospitals limited
Coordinator of this site? Confirm its status
KolkataIndiaUnknown status
Bangur Institute of Neurosciences (BIN) and Institute of Post Graduate Medical Education and Research (IPGME&R)
Coordinator of this site? Confirm its status
KolkataIndiaUnknown status
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
All India Institute of Medical Sciences (AIIMS), New Delhi
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Indraprastha Apollo Hospital
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Institute of Human Behaviour and Allied Sciences
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Apollo Speciality Hospital - Teynampet
Coordinator of this site? Confirm its status
Tamil NaduIndiaUnknown status
Christian Medical College Vellore
Coordinator of this site? Confirm its status
VelloreIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.