Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease (REGEN-BRAIN©)

TITLE:
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 Dimentia | Late Onset Alzheimer's Disease | Neurodegenerative Disease
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.