Summary:
A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.
- 50 Years to 87 Years
- Meets National Institute on Aging and Alzheimer's Association Research Framework criteria for individuals in clinical Stage 4 or 5 of the Alzheimer's continuum.
- Evidence for AD pathophysiology, confirmed either prior to or during screening.
- MMSE score ≥ 16 and ≤ 27 at screening.
- Clinical Dementia Rating - Global Score must be 0.5, 1 or 2.
- If receiving background AD medications, the dosing regimen must be stable for at least 12 weeks prior to randomization.
- The subject has been a non-smoker for at least 3 years.
- Availability of a study partner
- Individuals who have participated in a clinical study with an investigational drug targeting the underlying AD process may be permitted to participate in this study.
Qualified Participants May Receive:
• No-cost study medication
• No-cost study-related care from a local doctor
• Compensation