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Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Active Not RecruitingPhase 2

Sponsor: University of Arizona

Conditions: Alzheimer Dementia, Late Onset Alzheimer Disease, Neurodegenerative Diseases

Interventions: Allopregnanolone, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Main Inclusion Criteria:

* Men and postmenopausal women
* Age 55 to 80 years old
* Meets NIA-AA criteria for probable AD dementia
* MMSE of 20-26
* Plasma p-Tau217 positive
* Geriatric Depression Scale short form (GDS-S) score of ≤ 6
* No medical contraindications to participation
* Capacity to provide informed consent at screening

Main 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.
* No evidence of AD-like pattern of brain atrophy

Locations (9)

Scottsdale, Arizona, United States
Tucson, Arizona, United States
Costa Mesa, California, United States
Santa Ana, California, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Waltham, Massachusetts, United States