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 who carry the APOEε4 gene and experiencing 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

  • APOE ε4 positive

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

  • No medical contra indications 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.

More information can be found at Clinicaltrials.gov