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NCT06566170

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

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
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Record History

All 7 versions: 5 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion moved earlier from Feb 2033 to May 2031
  2. Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Site details revised
  3. Enrollment target: 3060 to 6250
    • Primary and study completion dates: May 2031 to Feb 2033
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Oct 7, 2024
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (9)

Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline
Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline
Change from Baseline Over Time (Semi-Annually) in DS Total Score
Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score
Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score
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Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score
Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ)
Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ
Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ

Arms and interventions

Donanemab Group + Usual Care

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

Usual Care Group

Participants will receive usual care.

Drugs: Donanemab, Usual Care

Sites

1 site in 1 country

  • Rehabilitation & Neurological ServicesHuntsville, Alabama, United States