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Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Study acronym: REGEN-BRAIN©
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites: 10 to 9
    v11
  2. Enrollment target: 200 to 100v10 Show 6 more changesShow less
    • Primary completion date: Mar 2026 to Nov 18, 2026
    • Study sites: 8 to 10
    • Study completion date: Apr 2026 to Mar 18, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description shortened, about 3 words
  3. Primary completion date: Apr 2025 to Mar 2026
    • Study completion date: Dec 2026 to Apr 2026
    • Site contacts updated at 8 of 8 sites
    v9
  4. Study sites: 10 to 8
    • Collaborators revised (4)
    • Publications: details revised at 1 of 4 entries
    v8
  5. Study sites: 1 to 10v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 2025 to Apr 2025
    • Study completion date: Dec 2025 to Dec 2026
    • Start date changed from estimate of Sep 15, 2023 to Aug 15, 2023
  2. Start date: Jun 15, 2023 to Sep 15, 2023v5
  3. Start date: Jan 2023 to Jun 15, 2023
    • Primary completion date: Jan 2025 to Jun 2025
    • Study completion date: Jun 2025 to Dec 2025
    v4
  4. Primary completion date: Jan 2024 to Jan 2025
    • Start date: Nov 2021 to Jan 2023
    • Study completion date: Jun 2024 to Jun 2025
    v3
  5. Start date: May 2021 to Nov 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
University of Arizona
124 trials monitored
See 4 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
A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease.
Trial Details
NCT Number NCT04838301
Lead Sponsor University of Arizona
Collaborators: National Institute on Aging (NIA), Syneos Health, University of Southern California, ADM Diagnostics
Conditions
(from sponsor)		 Alzheimer Dementia, Late Onset Alzheimer Disease, Neurodegenerative Diseases
Related terms Alzheimer Disease, Neurodegenerative Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov