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Small Molecule

Simufilam for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Cassava Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Subjects must have completed the PTI-125-04 study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 96 weeks
Awards & highlights

Study Summary

This trial will study the long-term effects of simufilam, a drug for Alzheimer's disease, on safety and treatment.

Who is the study for?
This clinical trial is open to individuals with mild-to-moderate Alzheimer's Disease who have completed the PTI-125-04 study. It's designed to assess long-term treatment effects and safety over a period of 96 weeks.Check my eligibility
What is being tested?
The trial is testing simufilam, given at a dose of 100 mg twice daily (b.i.d.). The focus is on understanding its safety and effectiveness when used over an extended time in those previously involved in the initial Phase 2 study.See study design
What are the potential side effects?
Potential side effects include reactions commonly associated with medications such as changes in lab results, urine abnormalities, altered vital signs, heart-related issues seen on ECGs, and any adverse events that may be reported.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Event Monitoring
Secondary outcome measures
NPI

Side effects data

From 2021 Phase 1 trial • 24 Patients • NCT04932655
4%
headache
4%
diarrhoea
4%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 3 Low-fat Fed Simufilam
Phase 3 High-fat Fed Simufilam
Fasted Phase 3 Simufilam
Fasted Phase 2 Simufilam

Trial Design

1Treatment groups
Experimental Treatment
Group I: Simufilam 100 mgExperimental Treatment1 Intervention
simufilam 100 mg oral tablets, b.i.d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
simufilam
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Cassava Sciences, Inc.Lead Sponsor
7 Previous Clinical Trials
3,749 Total Patients Enrolled

Media Library

simufilam (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05352763 — Phase 2
simufilam (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352763 — Phase 2
Alzheimer's Disease Research Study Groups: Simufilam 100 mg
Alzheimer's Disease Clinical Trial 2023: simufilam Highlights & Side Effects. Trial Name: NCT05352763 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still taking participants for this research?

"This study is not recruiting patients at the moment, according to the most recent update on clinicaltrials.gov. The posting date was May 12th, 2022 and the last update was October 6th, 2022. There are 561 other trials that are open for enrollment if you're interested."

Answered by AI

When might the FDA approve simufilam?

"While there is early evidence supporting simufilam's safety, it hasn't been proven effective yet and thus received a score of 2."

Answered by AI
~40 spots leftby Oct 2025