Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer's Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial
medical condition:
Alzheimer Dementia | Late Onset Alzheimer Disease | Neurodegenerative Diseases
age:
55-80yrs
sex/gender:
All
Overview
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.
Study Details
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.
