Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer's Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial
University of Arizona
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.
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 allocati…
Eligibility
- Age range
- 55–80 years
- Sex
- All
- Healthy volunteers
- No
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 * Hist…
Interventions
- DrugAllopregnanolone
Allopregnanolone 4mg IV via 30-minute infusion, once per week.
- OtherPlacebo
Normal saline solution IV via 30-minute infusion, once per week
Locations (10)
- Perseverance Research CenterScottsdale, Arizona
- University of Arizona / Clinical & Translational Sciences Research CenterTucson, Arizona
- ATP Clinical ResearchCosta Mesa, California
- Wake Research-PRI, LLCLos Alamitos, California
- Syrentis Clinical ResearchSanta Ana, California
- Optimus U CorporationMiami, Florida