Actively Recruiting
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Led by University of Arizona · Updated on 2026-03-13
100
Participants Needed
10
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and postmenopausal women
- Age 55 to 80 years old
- Meets NIA-AA criteria for probable Alzheimer's disease dementia
- Mini-Mental State Exam (MMSE) score of 20 to 26
- Positive plasma p-Tau217 test
- Geriatric Depression Scale short form (GDS-S) score of 6 or less
- No medical reasons preventing participation
- Able to give informed consent at screening
You will not qualify if you...
- Dementia other than probable Alzheimer's disease
- Use of benzodiazepines, anticonvulsants, antipsychotics, or drugs interacting with GABA-A receptor
- History of stroke with modified Hachinski Ischemic Scale score greater than 4
- History of seizure disorder, focal brain lesion, or traumatic brain injury
- Cancer diagnosis within the last 5 years
- Unstable or serious heart, kidney, or liver disease
- MRI showing significant brain abnormalities including ARIA-E, multiple microhemorrhages, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or lesions
- Any conditions preventing MRI studies
- No signs of Alzheimer's-type brain atrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Perseverance Research Center
Scottsdale, Arizona, United States, 85253
Actively Recruiting
2
University of Arizona / Clinical & Translational Sciences Research Center
Tucson, Arizona, United States, 85721
Actively Recruiting
3
ATP Clinical Research
Costa Mesa, California, United States, 92626
Actively Recruiting
4
Wake Research-PRI, LLC
Los Alamitos, California, United States, 90720
Withdrawn
5
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Terminated
6
Optimus U Corporation
Miami, Florida, United States, 33135
Actively Recruiting
7
Miami Jewish Health
Miami, Florida, United States, 33137
Actively Recruiting
8
Combined Research Orlando
Orlando, Florida, United States, 32807
Terminated
9
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
10
MedVadis Research
Waltham, Massachusetts, United States, 02451
Actively Recruiting
Research Team
C
Claudia M Lopez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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