Not 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

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD / mild AD dementia•Amyloid biomarker required (plasma)•MMSE 20-28•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)•Frequency and Severity of Infusion-Related Reactions

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID27847

Secondary IDI5T-IN-AACXEli Lilly and Company

NCT IDNCT07838155

Timeline

Milestones

Study first posted2026-09-24actual

Last update posted2026-10-15actual

Study start2026-11estimated (month precision)

Primary completion2030-09estimated (month precision)

Study completion2030-09estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Amyloid biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline through Week 76

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

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

Time frame:Baseline Up to Week 24, 52

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Frequency and Severity of Infusion-Related Reactions

Time frame:Through Week 52

event count, event

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline through Week 76

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.