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.