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

NCT07838155 | Not Yet Recruiting Phase 4

• 2 other identifiers: 27847I5T-IN-AACX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)

  Baseline Up to Week 24, 52

• Frequency and Severity of Infusion-Related Reactions

  Through Week 52

Secondary Outcomes (2)

• Change from Baseline in Mini Mental State Examination (MMSE) Score

  Baseline through Week 76

• Change from Baseline in Plasma Phosphorylated Tau217 (P-tau217)

  Baseline through Week 76

Study Arms (1)

Donanemab

EXPERIMENTAL

Donanemab administered intravenously (IV)

Drug: Donanemab

Interventions

Donanemab DRUG

Donanemab administered IV

Also known as: LY3002813

Donanemab

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

Manipal Hospital

Bangalore, 560017, India

Location

NIMHANS

Bangalore, 560029, India

Location

Aster CMI Hospital

Bangalore, 560092, India

Location

Apollo Multispeciality Hospitals limited

Kolkata, 700054, India

Location

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

Mumbai, 400053, India

Location

Indraprastha Apollo Hospital

New Delhi, 110076, India

Location

Institute of Human Behaviour and Allied Sciences

New Delhi, 110095, India

Location

Apollo Speciality Hospital - Teynampet

Tamil Nadu, 600006, India

Location

Christian Medical College Vellore

Vellore, 632 004, India

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

donanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Locations

IN (9)