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Simufilam for Alzheimer's Disease(REFOCUS-ALZ Trial)

Verified Trial
Phase 3
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
Do you have early symptoms of dementia or Alzheimer's?
Do you have a study partner who is willing to attend screening with you?
Must not have
Be younger than 18 years old
Timeline
Screening 30 days
Treatment 12 months
Follow Up12 months
Awards & highlights
Pivotal Trial

REFOCUS-ALZ Trial Summary

This trial will test the safety and effectiveness of simufilam, given twice daily for 76 weeks, in people with mild-to-moderate Alzheimer's disease.

REFOCUS-ALZ Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Are you experiencing the initial signs of memory loss or Alzheimer's disease?
Select...
You need to bring someone with you to the screening appointment.

REFOCUS-ALZ Trial Timeline

Screening ~ 30 days
Treatment ~ 12 months
Follow Up ~12 months
This trial's timeline: 30 days for screening, 12 months for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Secondary outcome measures
Change from baseline in plasma biomarker SavaDx
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Change from baseline in the MMSE
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

REFOCUS-ALZ Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Simufilam 50 mgExperimental Treatment1 Intervention
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Group II: Simufilam 100 mgExperimental Treatment1 Intervention
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks

Find a Location

Who is running the clinical trial?

Cassava Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
2,803 Total Patients Enrolled
Premier Research Group plcIndustry Sponsor
61 Previous Clinical Trials
68,227 Total Patients Enrolled
Lindsay BurnsStudy ChairCassava Sciences

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05026177 — Phase 3
Alzheimer's Disease Research Study Groups: Simufilam 50 mg, Placebo, Simufilam 100 mg
Alzheimer's Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05026177 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026177 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05026177 — Phase 3

Frequently Asked Questions

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

When might Simufilam be available for public use?

"Simufilam has undergone Phase 3 trials, so there is some evidence of its efficacy and multiple rounds of data supporting its safety. This gives it a score of 3 on our team's safety scale."

Answered by AI

Are there other locations where this experiment is taking place?

"This research is being conducted out of 79 different facilities, which are situated in places such as Miami, East Syracuse, Winston-Salem, and other locations. If you are interested in participating, it would be most convenient to select a site close to your home to minimize travel requirements."

Answered by AI

Are there any prerequisites to participating in this clinical research?

"The requirements to take part in this trial are that patients must be between the ages of 50 and 87, and have a diagnosis of Alzheimer's Disease. They are looking for around 1083 participants in total."

Answered by AI

What are the most important goals of this research project?

"The aim of this clinical trial is to observe changes in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) from baseline to Week 76. Additionally, the trial will also track changes in the Clinical Dementia Rating Sum of Boxes (CDR-SB), the integrated Alzheimer's Disease Rating Scale (iADRS), and the Zarit Burden Interview (ZBI) over the same time period."

Answered by AI

Does this research study allow for participants who are above the age of 40?

"The current recruitment drive is for individuals who are between 50-87 years old."

Answered by AI

Are we still looking for new volunteers for this experiment?

"The clinical trial mentioned is still recruiting patients, as of September 28th, 2022. This information can be found on clinicaltrials.gov, where the trial was first posted on November 18th, 2021."

Answered by AI

How many people are allowed to be in this clinical trial at any given time?

"The sponsor, Cassava Sciences, Inc., needs a total of 1083 patients that meet the clinical trial's inclusion criteria in order to proceed. The study will be conducted out of different locations including Gonzalez MD & Aswad MD Healthcare Services / Optimus U in Miami, Florida and Velocity Clinical Research, Formerly Clarity Clinical Research in East Syracuse, New York, Florida and Velocity Clinical Research, Formerly Clarity Clinical Research in East Syracuse, New York."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
California
Other
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
Neurology Center of North Orange County
California Research Insitute
Accellacare Research of Winston-Salem
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0

Why did patients apply to this trial?

I want to be ahead of any problems. Mother and her 2 siblings all had AD. Starting to forget things. Can't remember stuff.
PatientReceived no prior treatments
To possibly help with my memory and possibly help others. I’d like to slow the progression of Alzheimer’s if possible.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Are there any trials in NC? How long do screening visits take? How many follow-ups will there be for this trial?
PatientReceived 2+ prior treatments
Are you actively recruiting for this Phase III Trial? What study drugs would I be administered and what are the side effects? How many visits would I need to be part of?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Parkinson's Disease and Movement Disorders Center of Boca Raton: < 48 hours
  2. California Research Insitute: < 48 hours
  3. Accellacare Research of Winston-Salem: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
2021. "Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05026177.
All > Alzheimers Disease Boston > New Jersey
~449 spots leftby May 2025
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