A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease

NCT ID
NCT07838155
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Eli Lilly and Company
Conditions
Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 50 participants (Estimated).

What is being studied

  • Intervention: donanemab
  • Drug: Donanemab

Who may be eligible

Ages
60 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Criteria: * 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. * 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.

Study locations

9 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: India

Sample of listed locations

  • Aster CMI Hospital — Bangalore, 560092, India — Site recruitment status not specified in the registry data
  • Manipal Hospital — Bangalore, 560017, India — Site recruitment status not specified in the registry data
  • NIMHANS — Bangalore, 560029, India — Site recruitment status not specified in the registry data
  • Apollo Multispeciality Hospitals limited — Kolkata, 700054, India — Site recruitment status not specified in the registry data
  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute — Mumbai, 400053, India — Site recruitment status not specified in the registry data
  • Indraprastha Apollo Hospital — New Delhi, 110076, India — Site recruitment status not specified in the registry data
  • Institute of Human Behaviour and Allied Sciences — New Delhi, 110095, India — Site recruitment status not specified in the registry data
  • Apollo Speciality Hospital - Teynampet — Tamil Nadu, 600006, India — Site recruitment status not specified in the registry data
  • Christian Medical College Vellore — Vellore, 632 004, India — Site recruitment status not specified in the registry data

Study details

Start date
October 1, 2026
Primary completion date
July 1, 2030
Completion date
July 1, 2030
First posted
September 24, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07838155
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07838155 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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