Alzheimer’s Disease Studies

NEUROTROPE-NTRP-101-204

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing Safety, Tolerability and Long-term Efficacy of Bryostatin in the Treatment of Moderately Severe Alzheimer’s Disease Subjects Not Receiving Memantine Treatment.

  • PI: JAMES STEVENS, MD
  • CONTACT PATTI EXT 2202
  • Study Drug: Bryostatin 1; matching Placebo
  • Study Duration: Approximately 2 years

KEY INCLUSION CRITERIA

  • Male and female subjects 55-85 years of age inclusive.
  • Cognitive deficit present for at least 2 years that meet the diagnostic criteria for probable Alzheimer’s dementia.1 The diagnosis must be confirmed at the time of the screening visit
  • MMSE-2 score of 10-18 inclusive (applies to Screening Visit only)
  • Neuroimaging computerized tomography (CT) or Magnetic Resonance Imaging (MRI) within the last 24 months consistent with a diagnosis of probable AD without any other clinically significant co-morbid pathologies.
  • Subjects who are memantine naïve or have been off memantine for at least 90 days prior to initial treatment with study drug.

ALZHEON-ALZ-801-AD301

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer’s Disease and APOE4/4 Genotype.

  • PI:  JAMES STEVENS, MD
  • CONTACT PATTI EXT 2202
  • Phase 3 Study of ALZ-801 in APOE4/4 Early AD Subjects.
  • Treatment Duration 18 months

KEY INCLUSION CRITERIA

  • Male or female between the ages of 50 and 80 years (inclusive).
  • Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer’s Association (NIA-AA) Working Group Criteria.
  • Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
  • MMSE score at Screening of 22 to 30 (inclusive).

KEY EXLUSION CRITERIA

  • Currently taking memantine or has taken memantine within 12 weeks prior to the Screening.