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Simufilam for Alzheimer's Disease(REFOCUS-ALZ 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 CriteriaYou will be eligible if you check “Yes” for the criteria below
REFOCUS-ALZ Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
REFOCUS-ALZ Trial Design
Find a Location
Who is running the clinical trial?
- The subject has not smoked cigarettes for at least 3 years., and not meeting the study inclusion criteria, was found in 96 of the 377 (25%) individuals screenedThe individual meets the criteria for people in clinical Stage 4 or 5 of the Alzheimer's continuum, as set by the National Institute on Aging and the Alzheimer's Association.Are you experiencing the initial signs of memory loss or Alzheimer's disease?To be eligible for the study, participants must have been receiving stable background doses of any AD medications for at least 12 weeks prior to randomization.If you take medication for Alzheimer's disease, you must have been taking the same dosage for at least 3 months.You have not smoked or used any tobacco products for at least 3 years.You need to bring someone with you to the screening appointment.
- Group 1: Simufilam 50 mg
- Group 2: Placebo
- Group 3: Simufilam 100 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 30 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Parkinson's Disease and Movement Disorders Center of Boca Raton: < 48 hours
- California Research Insitute: < 48 hours
- Accellacare Research of Winston-Salem: < 48 hours
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