Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Launched by UNIVERSITY OF ARIZONA · Apr 6, 2021
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Allopregnanolone to see if it is safe and effective for people with mild Alzheimer's disease. The goal is to find out if this therapy can help slow down the progression of the disease and improve the quality of life for patients. The trial is currently looking for participants aged 55 to 80 years old, who are men or postmenopausal women diagnosed with probable Alzheimer's disease and show specific signs of cognitive decline.
To participate, individuals must meet certain criteria, such as having a certain level of cognitive ability and being positive for a specific genetic marker called APOE ε4. Participants will receive either the treatment or a placebo (a substance with no active medication) without knowing which one they are getting. Throughout the trial, they will have regular check-ins and assessments to monitor their health and any changes in their condition. This study is an important step in exploring new options for those affected by Alzheimer's disease.
Gender
ALL
Eligibility criteria
- Inclusion 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
- Exclusion Criteria:
- • 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.
About University Of Arizona
The University of Arizona is a leading research institution dedicated to advancing healthcare through innovative clinical trials and studies. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources and expertise to explore new therapeutic approaches and enhance patient outcomes. Committed to ethical research practices and community engagement, the University of Arizona fosters an environment that promotes scientific discovery and the translation of research findings into clinical applications. Its clinical trial initiatives encompass a wide range of medical disciplines, reflecting the institution's mission to improve health and well-being locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Costa Mesa, California, United States
Santa Ana, California, United States
Miami, Florida, United States
Winter Park, Florida, United States
Waltham, Massachusetts, United States
Miami, Florida, United States
Scottsdale, Arizona, United States
Los Alamitos, California, United States
Coral Gables, Florida, United States
Orlando, Florida, United States
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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