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Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients

NCT04388254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-04-22

Study results available
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Summary

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

Interventions

DRUG

Simufilam 100 mg oral tablet

Simufilam 100 mg oral tablet for b.i.d. administration

DRUG

Placebo

Matching placebo oral tablets

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsay Burns, PhD · Cassava Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2023-11-09
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT04388254 on ClinicalTrials.gov