Overview

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Arizona
Collaborators:
ADM Diagnostics, Inc.
National Institute on Aging (NIA)
Syneos Health
University of Southern California
Treatments:
Pregnanolone
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.