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Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1125

Last updated 2025-09-22

Study results available
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Summary

A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Simufilam

Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 76 weeks at a dose of 50 mg or 100 mg.

DRUG

Placebo

Matching placebo given b.i.d. for 76 weeks

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • James Kupiec, MD · Cassava Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026177 on ClinicalTrials.gov