RECRUITING

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Conditions

Alzheimer Dementia Late Onset Alzheimer Disease Neurodegenerative Diseases Mild Alzheimer Disease Regenerative Therapeutic APOE ε4 Neurogenesis Allopregnanolone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-15

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04838301

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.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Claudia M Lopez, BS

CONTACT

520-626-6276

claudiml@arizona.edu

Principal Investigator

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 Locations (Sites)

Perseverance Research Center

Scottsdale, Arizona, 85253

United States

ATP Clinical Research

Costa Mesa, California, 92626

United States

Wake Research

Los Alamitos, California, 90720

United States

Syrentis Clinical Research

Santa Ana, California, 92705

United States

Linfritz Research Institute inc

Coral Gables, Florida, 33134

United States

Optimus U Corporation

Miami, Florida, 33135

United States

Miami Jewish Health

Miami, Florida, 33137

United States

Combined Research

Orlando, Florida, 32807

United States

Conquest Research

Winter Park, Florida, 32789

United States

MedVadis Research

Waltham, Massachusetts, 02451

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-08-15

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Mild Alzheimer Disease
Regenerative Therapeutic
APOE ε4
Neurogenesis
Allopregnanolone

Additional Relevant MeSH Terms

Alzheimer Dementia
Late Onset Alzheimer Disease
Neurodegenerative Diseases