Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients
Active, not recruiting
National Institute on Aging (NIA)
Phase 2
A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for
participants of the previous simufilam studies as wells as additional new mild-to-moderate
Alzheimer's disease subjects for a total of 200 participants. All participants will receive
simufilam 100 mg tablets twice daily for one year, followed by a 6-month randomized,
double-blind period where subjects will either continue on active treatment or be switched to
placebo. The study concludes with an additional 6-month open-label treatment period. Clinic
visits are every month or month and a half in the first year, and every 3 months in the
second year with an additional visit at Month 13. Cognition and neuropsychiatric symptoms are
evaluated.
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