Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Description

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

Alzheimer Dementia, Late Onset Alzheimer Disease, Neurodegenerative Diseases

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Study Overview

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Study Details

Study overview

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.

Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer's Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Condition
Alzheimer Dementia
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Perseverance Research Center, Scottsdale, Arizona, United States, 85253

Costa Mesa

ATP Clinical Research, Costa Mesa, California, United States, 92626

Los Alamitos

Wake Research, Los Alamitos, California, United States, 90720

Santa Ana

Syrentis Clinical Research, Santa Ana, California, United States, 92705

Coral Gables

Linfritz Research Institute inc, Coral Gables, Florida, United States, 33134

Miami

Optimus U Corporation, Miami, Florida, United States, 33135

Miami

Miami Jewish Health, Miami, Florida, United States, 33137

Orlando

Combined Research, Orlando, Florida, United States, 32807

Winter Park

Conquest Research, Winter Park, Florida, United States, 32789

Waltham

MedVadis Research, Waltham, Massachusetts, United States, 02451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men and postmenopausal women
  • * Age 55 to 80 years old
  • * Meets NIA-AA criteria for probable AD dementia
  • * MMSE of 20-26
  • * APOE ε4 positive
  • * Geriatric Depression Scale short form (GDS-S) score of ≤ 6
  • * No medical contraindications to participation
  • * Capacity to provide informed consent at screening
  • * 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.

Ages Eligible for Study

55 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Arizona,

Roberta D Brinton, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

Lon Schneider, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Gerson D Hernandez, MD, MPH, STUDY_DIRECTOR, University of Arizona

Study Record Dates

2026-12