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Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD

NCT02221622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-07-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. The primary goal is to determine the maximally tolerated dose.

Conditions

Interventions

DRUG

Allopregnanolone injection (intravenous solution)

Allopregnanolone intravenous infusion

DRUG

Placebo injection (intravenous solution)

Placebo intravenous infusion

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Roberta D Brinton, Ph.D. · University of Southern California

  • Lon S Schneider, M.D. · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02221622 on ClinicalTrials.gov