Recruiting

Donanemab & Usual Care

Sponsor:

Eli Lilly and Company

Code:

NCT06566170

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Donanemab

Usual Care

Study Details

Brief summary:

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

Conditions

Alzheimer Disease

Study ID

NCT06566170

Start date

Oct 7, 2024

Status verified date

Oct, 2025

Completion date

Feb, 2033

Anticipated

Primary completion date

Feb, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants

  • are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \[EHR\] is required prior to screening)
  • have a Telephone Interview for Cognitive Status (TICS) score of ≥21
  • presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \[CSF\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)
  • have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and
  • have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.

Exclusion Criteria:

  • have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)
  • have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (>12 months) institutional-level care, serious psychiatric illness, etc.)
  • are currently enrolled or intend to enroll in a clinical trial of another investigational product, and
  • have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).

Study Design

Enrollment

6250 participants

Anticipated

Interventions and Outcome Measures

Arms

Donanemab Group + Usual Care

Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care

Usual Care Group

Participants will receive usual care.

Interventions

Donanemab

Administered IV

Usual Care

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Primary outcome measure

  • Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS]) [ Time Frame: Up to 5 Years ]

Central Contacts and Locations

Central contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559clinical_inquiry_hub@lilly.com

Locations

Rehabilitation & Neurological Services

Recruiting

Huntsville, Alabama, United States, 35805-4046

Principal Investigator:

Belinda Savage-Edwards

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2025-10-09.