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Simufilam for Alzheimer's Disease (RETHINK-ALZ Trial)
RETHINK-ALZ Trial 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.
RETHINK-ALZ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRETHINK-ALZ Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RETHINK-ALZ Trial Design
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Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
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- You have mild to moderate dementia, with a score between 0.5 and 2 on a global rating scale.You may not participate if you have already taken part in a study involving an experimental drug for the same condition.My Alzheimer's medication dose has been the same for the last 12 weeks.You have struggled with alcohol or drug addiction in the past two years.My Alzheimer's medication dose has been the same for the last 12 weeks.I am in the middle or late stages of Alzheimer's according to NIA-AA guidelines.You have evidence of Alzheimer's disease pathology, either prior to or during screening.I have had a seizure in the last year.My BMI is between 18.5 and 35.My condition is in the middle to late stages of Alzheimer's according to specific research criteria.You cannot participate if you have previously been in a clinical trial for an experimental drug that targets Alzheimer's disease.I have not smoked for at least 3 years.My diabetes or high blood pressure is not well-controlled.I have a brain condition, not Alzheimer's, that significantly affects my memory.You have a study partner.You must have a mild to moderate level of dementia based on your clinical evaluation score.I have had a stroke or mini-stroke in the last year.I have not had thoughts of suicide in the last 3 months or acted on them in the last year.I have a significant heart condition.You recently had a serious head injury that may be affecting your ability to think clearly.I am currently taking aducanumab.I have not smoked for at least 3 years.I'm sorry, but "Key" is not a clear criterion. Can you please provide more context or information?My BMI is either below 18.5 or above 35.You have a score higher than 8 in a test that measures depression in older adults.My sleep apnea is likely affecting my thinking or memory.You have a mental health condition other than Alzheimer's disease that could affect your ability to complete the study tasks or follow the study guidelines.
- Group 1: Placebo
- Group 2: 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 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does Simufilam have any FDA-backed claims?
"Simufilam is currently being tested in a Phase 3 clinical trial, which means that while there is some data supporting efficacy, there is also extensive data supporting safety. Our team at Power has given it a safety score of 3."
What is the projected sample size of this research project?
"In order to carry out this experiment, 750 people that meet the necessary requirements must be found. The trial will be conducted by Cassava Sciences, Inc. at various locations, two of which are Q & T Research in Sherbrooke, Quebec and Clinical Research of Brandon, LLC (Tampa) in Tampa, Texas."
How many staff members are managing this trial at different locations?
"This international study is based out of Q & T Research in Sherbrooke, Quebec, Clinical Research of Brandon, LLC (Tampa) in Tampa, Texas, and Grayline Research Center in Wichita Falls, Massachusetts. Additionally, there are 85 other medical centres where this research is taking place."
For this particular trial, is the age limit set at 85 years or younger?
"As this study's enrolment requirements state, the age limit for participants is 87 years old while the minimum age is 50."
What aim does this clinical trial hope to realize?
"The goal of this 52-week study is to assess the impact of the intervention on patients' Alzheimer's disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scores. Secondary outcomes include changes in cognition and function as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB), as well as changes in plasma levels of SavaDx, a novel biomarker, and P-tau181, neurofilament light chain and GFAP, markers of AD pathology, neurodegeneration, and neuroinflammation."
Are currently enrolling any more participants for this experiment?
"That is accurate. The listing on clinicaltrials.gov does show that the study is presently looking for participants. The study was initially posted on 11/3/2021 and was most recently edited on 9/28/2022. The clinical trial is searching for 750 participants at 85 sites."
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?
Typically responds via
Most responsive sites:
- Senior Adults Specialty Research, Inc: < 24 hours
- ATP Clinical Research, Inc.: < 24 hours
- Mid Hudson Medical Research: < 48 hours
Average response time
- < 2 Days
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