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Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

Study acronym: PROGRESS-AD
StatusTerminated
PhasePhase 2
Started
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Record History

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  1. Trial terminated Sponsor's reason: The study was terminated early due to meeting pre-specified efficacy futility criteria at planned interim analysis. Show 5 more changesShow less
    • Primary completion date changed from estimate of Sep 30, 2026 to May 14, 2026
    • Study completion date changed from estimate of Nov 23, 2026 to Aug 18, 2026
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 17 of 97 sites
  2. Primary completion date: Nov 23, 2026 to Sep 30, 2026v9
  3. Re-verified, no change to tracked fieldsv8
  4. Study sites: 99 to 97v7
  5. Enrollment target: 359 to 367v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 282 to confirmed 359
    • Study sites: 104 to 99
    • Primary and study completion dates: Nov 16, 2026 to Nov 23, 2026
    v5
  2. Primary completion date: Dec 2, 2026 to Nov 16, 2026
    • Study completion date: Feb 26, 2029 to Nov 16, 2026
    • Eligibility criteria expanded, about 25 words
    • Site details revised at 41 of 104 sites
    v4
  3. Study completion date: May 16, 2029 to Feb 26, 2029
    • Site details revised at 94 of 104 sites
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 100 to 104
    • Start date changed from estimate of Oct 11, 2023 to Oct 20, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
Dementia
1,978 trials monitored
See 106 trials at risk
Alzheimer's Disease
1,253 trials monitored
See 71 trials at risk
The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.
Trial Details
NCT Number NCT06079190
Lead Sponsor GlaxoSmithKline
Collaborators: Alector Inc.
Conditions
(from sponsor)		 Alzheimer's Disease
Related terms Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Dementia, Mental Disorders, Nervous System Diseases
Enrollment 367 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov