Status:
RECRUITING
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Institute on Aging (NIA)
Syneos Health
Conditions:
Alzheimer Dementia
Late Onset Alzheimer Disease
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This is a proof-of-concept phase 2 clinical trial to investigate the long-term safety and efficacy of Allo to function as a regenerative therapeutic to restore structural integrity and cognitive funct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04838301
Start Date
August 15 2023
End Date
April 1 2026
Last Update
May 11 2025
Active Locations (8)
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1
Perseverance Research Center
Scottsdale, Arizona, United States, 85253
2
ATP Clinical Research
Costa Mesa, California, United States, 92626
3
Syrentis Clinical Research
Santa Ana, California, United States, 92705
4
Optimus U Corporation
Miami, Florida, United States, 33135