A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT06566170
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Donanemab — DRUG
    Administered IV
  • Usual Care — DRUG
    Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Study Details

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.

Key Dates

Start date
Oct 7, 2024
Status verified
Oct 2025
Primary completion
Feb 28, 2033
Completion
Feb 28, 2033

Study Design

Enrollment
6,250 participants (estimated)

Arms

  • Arm: Donanemab Group + Usual Care
    Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care
  • Arm: Usual Care Group
    Participants will receive usual care.

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

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Rehabilitation & Neurological ServicesHuntsvilleAlabama35805-4046
Belinda Savage-Edwards (PRINCIPAL_INVESTIGATOR)

Find similar trials in Huntsville, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Rehabilitation & Neurological Services· Huntsville, AL

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