For Physicians

 

ReGen-BRAIN is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept clinical trial of ALLO as a regenerative therapeutic for persons diagnosed with mild Alzheimer’s Disease. 

Inclusion Criteria

  • Men and postmenopausal women

  • Age 55 to 80 years old

  • Meets NIA-AA criteria for probable AD dementia

  • MMSE of 20-26

  • Geriatric Depression Scale short form (GDS-S) score of ≤ 6

  • No medical contra indications to participation

  • Capacity to provide informed consent at screening

Allo AD Phase 2 Study Design

 

 Exclusion Criteria

  • Dementia other than probable Alzheimer’s disease

  • Chronic use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex

  • Therapy with anti-amyloid drugs (e.g. aducanumab, lecanemab, etc.) within six (6) months of screening

  • History of stroke with a modified Hachinski Ischemic Scale score >4

  • History of seizure disorder, focal brain lesion, traumatic brain injury

  • Active or overt malignant disease other than cutaneous squamous cell carcinoma in situ or basal cell carcinoma

  • 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.

More information can be found at Clinicaltrials.gov