PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

Phase 2 Completed 64 enrolled Cassava Sciences, Inc. National Institute on Aging (NIA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.

Timeline

Start: 2019-09-09
Primary completion: 2020-03-31
Completion: 2020-03-31

Outcome

Mixed primary results

registry analysis (superiority test); Placebo Cohort vs Simufilam (PTI-125), 100 mg Tablets Cohort; p = 0.087; ANCOVA; note: P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance). NCT04079803 ↗

registry analysis (superiority test); Placebo Cohort vs Simufilam (PTI-125), 100 mg Tablets Cohort; p <0.0001; ANCOVA; note: P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance). NCT04079803 ↗

registry MEAN Placebo Cohort: -3.2 (Standard Deviation 14.8) pg/mL NCT04079803 ↗

registry MEAN Simufilam (PTI-125) 100 mg Tablets Cohort: -18.7 (Standard Deviation 10.4) pg/mL NCT04079803 ↗

Publications

Sever S. Role of actin cytoskeleton in podocytes. Pediatr Nephrol. 2021 Sep;36(9):2607-2614. doi: 10.1007/s00467-020-04812-z. Epub 2020 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simufilam	Small molecule	50 mg	Oral
Subject	Simufilam	Small molecule	100 mg	Oral