A 12-Month, Open-Label Safety Study of Simufilam Followed by a 6-Month Randomized Withdrawal and 6 Additional Months Open-Label in Mild-to-moderate Alzheimer's Disease Patients
Abstract
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.
Conditions: Alzheimer Disease.
Primary outcome: Change From Baseline in ADAS-Cog-11; Change From Baseline in ADAS-Cog-11 (Month 12 to Month 24); Safety and Tolerability (Open Label Abnormal Vital Signs); Safety and Tolerability (Randomize Withdraw Abnormal Vital Signs); Safety and Tolerability (Open Label Electrocardiogram Results); Safety and Tolerability (Randomize Withdraw Electrocardiogram Results); Safety and Tolerability (Open Label Abnormal Physical Examination); Safety and Tolerability (Randomize Withdraw Abnormal Physical Examination Findings); Safety and Tolerability (Open Label Abnormal Clinical Laboratory Results); Safety and Tolerability (Randomize Withdraw Abnormal Clinical Laboratory Results).
Enrollment: 220 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 220 participants or records.
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