Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

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.

Eligibility

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

Conditions4

Interventions1

Locations10 sites

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