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

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called allopregnanolone — a naturally occurring brain hormone — to see if it can slow memory decline and support brain cell regeneration in people with mild Alzheimer's disease. **You may be eligible if:** - You are a man or a postmenopausal woman between 55 and 80 years old - You have been diagnosed with probable Alzheimer's disease based on recognized medical criteria - You have mild memory impairment (a score of 20–26 on a standard memory test) - A blood test shows a positive marker associated with Alzheimer's (p-Tau217) - You have the mental capacity to consent to the study **You may NOT be eligible if:** - Your memory problems are caused by something other than Alzheimer's disease - You take medications such as benzodiazepines, antipsychotics, or anticonvulsants - You have a history of stroke, seizures, brain injury, or significant brain abnormalities on MRI - You have had cancer in the past 5 years - You have serious heart, kidney, or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Scottsdale, Arizona, United States

University of Arizona / Clinical & Translational Sciences Research Center

Tucson, Arizona, United States

ATP Clinical Research

Costa Mesa, California, United States

Wake Research-PRI, LLC

Los Alamitos, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Optimus U Corporation

Miami, Florida, United States

Miami Jewish Health

Miami, Florida, United States

Combined Research Orlando

Orlando, Florida, United States

Conquest Research

Winter Park, Florida, United States

MedVadis Research

Waltham, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04838301


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