Simufilam for Alzheimer Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Alzheimer Disease
Simufilam - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety and effectiveness of simufilam, a drug for Alzheimer's disease, for one year. 750 people with mild-to-moderate Alzheimer's will be given the drug or a placebo twice daily. The trial will assess cognitive enhancement and functional decline.

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline (Study Day 1) to Week 52

Week 52
Alzheimer's Disease
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Change from baseline in the Mini-Mental State Exam (MMSE)
Change from baseline in the Neuropsychiatric Inventory (NPI)
Viral Load result
Change from baseline in the integrated Alzheimer's Disease Rating Scale (iADRS)
Changes from baseline in plasma P-tau181, neurofilament light chain and GFAP
Changes from baseline in the plasma SavaDx biomarker

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

Simufilam 100 mg
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

750 Total Participants · 2 Treatment Groups

Primary Treatment: Simufilam · Has Placebo Group · Phase 3

Simufilam 100 mg
Drug
Experimental Group · 1 Intervention: Simufilam · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (study day 1) to week 52

Who is running the clinical trial?

Cassava Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
3,136 Total Patients Enrolled
5 Trials studying Alzheimer Disease
3,112 Patients Enrolled for Alzheimer Disease
Premier Research Group plcIndustry Sponsor
55 Previous Clinical Trials
33,113 Total Patients Enrolled
1 Trials studying Alzheimer Disease
1,083 Patients Enrolled for Alzheimer Disease
Jim Kupiec, MDStudy ChairCassava Sciences
2 Previous Clinical Trials
2,683 Total Patients Enrolled
2 Trials studying Alzheimer Disease
2,683 Patients Enrolled for Alzheimer Disease

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving background AD medications
You have a study partner.
You have evidence of Alzheimer's disease pathology, either prior to or during screening.
Individuals who have participated in a clinical study with an investigational drug targeting the underlying AD process may be permitted to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 27th, 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.

Who else is applying?

What state do they live in?
California28.6%
Ohio14.3%
Indiana14.3%
Other42.9%
How old are they?
18 - 6580.0%
65+20.0%
What site did they apply to?
Advanced Research Center, Inc50.0%
Sun Valley Research Center, Inc.25.0%
MD Clinical - Velocity Clinical Research25.0%
What portion of applicants met pre-screening criteria?
Met criteria83.3%
Did not meet criteria16.7%

How responsive is this trial?

Most responsive sites:
  1. Sun Valley Research Center, Inc.: < 48 hours
  2. Advanced Research Center, Inc: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email50.0%
Phone Call50.0%