Trials / Recruiting
RecruitingNCT04838301
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer's Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a proof-of-concept phase 2 clinical trial to investigate the long-term safety and efficacy of Allo to function as a regenerative therapeutic to restore structural integrity and cognitive function of the brain in participants with mild Alzheimer's disease (AD) dementia. Study participants will be male and female, diagnosed with probable AD, Mini-Mental State Exam (MMSE) 20 to 26, ages 55 to 80 years old. After a 2-4-week screening period, participants will be randomized to 4 mg Allo (administered intravenously over 30 minutes, once per week, in clinic) or matching placebo, 1:1 allocation, for a period of 6 months. After 6 months, all participants in the placebo group will be crossed-over to receive Allo for the remainder of the study (3 month open-label phase). Brain imaging to evaluate the primary endpoint will be conducted at baseline, 3 and 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Allopregnanolone | Allopregnanolone 4mg IV via 30-minute infusion, once per week. |
| OTHER | Placebo | Normal saline solution IV via 30-minute infusion, once per week |
Timeline
- Start date
- 2023-08-15
- Primary completion
- 2026-11-18
- Completion
- 2027-03-18
- First posted
- 2021-04-09
- Last updated
- 2026-03-13
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04838301. Inclusion in this directory is not an endorsement.