A Study of Donanemab (LY3002813) in Participants Who Comp... | NCT07602582

ID	Type	Description	Link
I5T-MC-AACY	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2026Actual

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2029Estimated

First Submitted Date

May 15, 2026

First Submission Date that Met QC Criteria

May 15, 2026

First Posted Date

May 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

550Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Donanemab	Experimental	Donanemab administered intravenously (IV)	Drug: Donanemab
Placebo	Placebo Comparator	Placebo IV	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donanemab	Drug	Administered IV	Donanemab
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)		Baseline through Week 130

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline as Measured by Cognitive Function Index (CFI)		Baseline through Week 130
Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.		Baseline through Week 130

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have completed study AACM Addendum 7.
Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
Contraindication to florbetapir F 18 PET.
Have had history of amyloid-targeting therapy treatment outside donanemab trials.
Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banner Alzheimer's Institute	Not yet recruiting	Phoenix	Arizona	85006	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

URL

https://vivli.org/

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D058225	Plaque, Amyloid

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms