Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Alzheimer Dementia,Late Onset Alzheimer Disease,Neurodegenerative Diseases
Age
55+
Phase
PHASE2
Participants Needed
200
Est. Completion Date
Dec 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
University of Arizona
ClinicalTrials.gov NCT Identifier
NCT04838301
Study Number
Allo-20-001
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