simufilam for Alzheimer's Disease (AD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cognitive Clinical Trials, Gilbert, AZ
Alzheimer's Disease (AD)+1 More
simufilam - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Subjects will be followed on ADAS-Cog11 and NPI until 96 weeks. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, GDS and C-SSRS.

Eligible Conditions

  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer's Disease (AD)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline to 96 Weeks

Baseline to 96 Weeks
ADAS-Cog11
NPI

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Alzheimer's Disease (AD)

Trial Design

1 Treatment Group

Simufilam 100 mg
1 of 1
Experimental Treatment

165 Total Participants · 1 Treatment Group

Primary Treatment: simufilam · No Placebo Group · Phase 2

Simufilam 100 mg
Drug
Experimental Group · 1 Intervention: simufilam · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
simufilam
2021
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 96 weeks
Closest Location: Cognitive Clinical Trials · Gilbert, AZ
Photo of arizona 1Photo of arizona 2Photo of arizona 3
2020First Recorded Clinical Trial
2 TrialsResearching Alzheimer's Disease (AD)
5 CompletedClinical Trials

Who is running the clinical trial?

Cassava Sciences, Inc.Lead Sponsor
5 Previous Clinical Trials
2,121 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.