CLINICAL TRIALS PROFILE FOR SIMUFILAM

Clinical Trials for simufilam

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04079803 ↗	PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Completed	National Institute on Aging (NIA)	Phase 2	This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.
NCT04079803 ↗	PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Completed	Cassava Sciences, Inc.	Phase 2	This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.
NCT04388254 ↗	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.
NCT04388254 ↗	Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients	Active, not recruiting	Cassava Sciences, Inc.	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.
NCT04932655 ↗	Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers	Completed	Worldwide Clinical Trials	Phase 1	This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy volunteers to estimate the effect of food on the PK of simufilam following oral 100 mg doses and to estimate its relative bioavailability compared to the earlier Phase 2 simufilam tablet in the fasted state. A total of twenty four (24) healthy volunteers (12 male and 12 female) will be enrolled into this study. Subjects will be randomly assigned to one of four treatment sequences (6 subjects/sequence).

Clinical Trial Conditions for simufilam

Condition Name

Condition Name
Intervention	Trials
Alzheimer Disease	5
Excretion	1
Healthy	1
Metabolism	1

Condition MeSH

Condition MeSH
Intervention	Trials
Alzheimer Disease	6

Clinical Trial Locations for simufilam

Trials by Country

Trials by Country
Location	Trials
United States	50
Canada	6

Trials by US State

Trials by US State
Location	Trials
Texas	5
Florida	5
New Jersey	4
Nebraska	4
Arizona	4

Clinical Trial Progress for simufilam

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Enrolling by invitation	2
Active, not recruiting	1

Clinical Trial Sponsors for simufilam

Sponsor Name

Sponsor Name
Sponsor	Trials
Cassava Sciences, Inc.	8
National Institute on Aging (NIA)	2
Premier Research International LLC	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	8
Other	3
NIH	2