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Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

NCT04838301 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Allopregnanolone

Allopregnanolone 4mg IV via 30-minute infusion, once per week.

OTHER

Placebo

Normal saline solution IV via 30-minute infusion, once per week

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Syneos Health

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • ADM Diagnostics

    collaborator UNKNOWN

  • University of Arizona

    lead OTHER

Principal Investigators

  • Roberta D Brinton, PhD · University of Arizona

  • Lon Schneider, MD · University of Southern California

  • Gerson D Hernandez, MD, MPH · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2026-11-18
Completion
2027-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838301 on ClinicalTrials.gov