RecruitingPhase 2NCT04838301
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
Sponsor
University of Arizona
Enrollment
100 participants
Start Date
Aug 15, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 55 YearsMax Age: 80 Years
Inclusion Criteria8
- 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
Exclusion Criteria9
- 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
Interventions
OTHERPlacebo
Normal saline solution IV via 30-minute infusion, once per week
DRUGAllopregnanolone
Allopregnanolone 4mg IV via 30-minute infusion, once per week.
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04838301
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