NCT04838301Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Mar 2021
- Start date
- Aug 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- University of Arizona
- Diseases
- Alzheimer disease
- NCT number
- NCT04838301
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Aug 2023 to the primary completion date, Nov 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Main Inclusion Criteria:
- Men and postmenopausal women
- Age 55 to 80 years old
- Meets NIA-AA criteria for probable AD dementia
- MMSE of 20-26
- Plasma p-Tau217 positive
- Geriatric Depression Scale short form (GDS-S) score of ≤ 6
- No medical contraindications to participation
- Capacity to provide informed consent at screening
- Main Exclusion Criteria:
- Dementia other than probable AD
- Use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex
- History of stroke with a modified Hachinski Ischemic Scale score \>4
- History of seizure disorder, focal brain lesion, traumatic brain injury
- History within the last 5 years of a primary or recurrent malignant disease
- Unstable or clinically significant cardiovascular, kidney or liver disease
- MRI indicative of any other significant abnormality, including but not limited to one or more significant ARIA-E or macro-hemorrhage findings, or multiple microhemorrhages (\>8), or Fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
- Any conditions that would contraindicate MRI studies.
- No evidence of AD-like pattern of brain atrophy
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ATP Clinical Research Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Optimus U Corporation Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Miami Jewish Health Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Combined Research Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Syrentis Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Perseverance Research Center Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of Arizona / Clinical & Translational Sciences Research Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| MedVadis Research Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.