High Dose Simufilam for Mild-to-Moderate Alzheimer's Disease (RETHINK-ALZ)
Start: November 3, 2021
End: October 2023
Enrollment: 750
What Is This Study About?
This Phase 3 clinical trial, named RETHINK-ALZ, will test the safety and effects of the experimental drug simufilam (100 mg) designed to slow cognitive and functional decline in older adults with mild-to-moderate Alzheimer's disease. All participants will be randomly assigned to receive either 100 mg tablets of simufilam or a placebo, twice daily, for one year. After the initial clinical exam at the start of the study, participants will receive a clinical evaluation after four weeks and then every three months until the end of the study. Testing will include neurological exams, laboratory tests, electrocardiograms, questionnaires, and interviews. Some study locations may also analyze blood samples or cerebral spinal fluid (optional) to measure the levels of proteins associated with Alzheimer's disease. Researchers will monitor all participants for safety throughout the study and measure changes in cognitive function and mobility.
Do I Qualify To Participate in This Study?
Minimum Age: 50 Years
Maximum Age: 87 Years
Must have:
- Diagnosis of mild or moderate Alzheimer's disease
- Mini-Mental State Exam score of 16 to 27
- Clinical Dementia Rating Global Score of 0.5, 1, or 2
- Evidence of brain changes associated with Alzheimer's disease, based on MRI brain scans or other tests, either before or during study screening
- If taking any medications for Alzheimer's disease, the dosage must be stable for at least three months before starting the study
- Nonsmoker for at least three years
- Availability of a study partner
Must NOT have:
- Any condition, disease, or injury that could significantly contribute to the participants cognitive impairment including:
- Neurologic condition, other than Alzheimer's disease
- Serious head trauma
- Sleep apnea
- Any current primary psychiatric diagnosis, other than Alzheimer's disease, which could interfere with cognitive assessment or the ability to complete study procedures
- Geriatric Depression Scale score > 8
- Suicidal ideation during the past three months or suicidal behavior during the past year
- Alcohol or substance use disorder within two years of study screening
- Evidence of vascular disease (i.e., damaged blood vessels) or other signs of disease, based on MRI brain scan
- History of seizure, stroke, or transient ischemic attack in the past two years
- Insufficiently controlled diabetes or high blood pressure
- History or diagnosis of significant cardiac disease
- Body mass index < 18.5 or > 350
- Currently taking aducanumab
- COVID-19 infection within three months of screening. If no history of a prior COVID-19 infection, must be fully vaccinated for COVID-19 at least two weeks prior to starting study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Study Contact
Study Director
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
| Arizona | |
|---|---|
|
MDFirst Research
Chandler, AZ 85286
Recruiting
Hemant Pandey, MD |
|
|
CCT Research - Gilbert Neurology Partners
Gilbert, AZ 85297
Not yet recruiting
Jonathan Hodgson, DO |
|
|
Xenoscience, Inc.
Phoenix, AZ 85004
Recruiting
Stephen Flitman, MD |
|
| California | |
|
Advanced Research Center, Inc
Anaheim, CA 92805
Recruiting
Steven Macina, MD |
|
|
Axiom Research, LLC
Colton, CA 92324
Recruiting
Jon Messinger, MD |
|
|
ATP Clinical Research, Inc.
Costa Mesa, CA 92626
Recruiting
Gustavo Alva, MD |
|
|
Sun Valley Research Center, Inc.
Imperial, CA 92251
Recruiting
Bernard Ng, MD |
|
|
Senior Clinical Trials
Laguna Hills, CA 92653
Recruiting
Robert Feldman, MD |
|
|
Artemis Institute for Clinical Research
Riverside, CA 92503
Recruiting
Katrina Patrick, MD |
|
|
Syrentis Clinical Research
Santa Ana, CA 92705
Recruiting
John Duffy, MD |
|
| Colorado | |
|
Mountain Neurological Research Center
Basalt, CO 81621
Recruiting
Alison Allen, MD |
|
|
Colorado Neurological Research Center, PC
Denver, CO 80210
Not yet recruiting
Adam Wolff, MD |
|
| Florida | |
|
Topaz Clinical Research
Apopka, FL 32703
Recruiting
Tirso Negron, MD |
|
|
Neurology Offices of South Florida
Boca Raton, FL 33428
Recruiting
Brian Costell, MD |
|
|
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
Recruiting
Wendy Bond, MD |
|
|
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, FL 33009
Recruiting
Beth Safirstein, MD |
|
|
Galiz Research
Hialeah, FL 33016
Recruiting
Luis Pedraza |
|
|
CNS Healthcare - Jacksonville
Jacksonville, FL 32256
Recruiting
John Mark Joyce, MD |
|
|
Charter Research
Lady Lake, FL 32792
Recruiting
Jeffrey Norton, MD |
|
|
Parker Jewish Institute
Lauderhill, FL 33319
Recruiting
Alana Doonachar |
|
|
Segal Trials - West Broward Outpatient Site
Lauderhill, FL 33319
Not yet recruiting
Kadian Watson |
|
|
ClinCloud
Maitland, FL 32751
Recruiting
Jessica El Meskouri, MD |
|
|
Central Miami Medical Institute (GMI)
Miami, FL 33125
Recruiting
Leonardo Alonso, MD |
|
|
New Horizon Research Center
Miami, FL 33165
Recruiting
Roxanne Vazquez |
|
|
Quantam Clinical Trials
Miami Beach, FL 33140
Recruiting
Gene Neytman, MD |
|
|
South Florida Research Phase I-IV INC
Miami Springs, FL 33166
Recruiting
Belkis Delgado, MD |
|
|
Combined Research Orlando Phase I-IV
Orlando, FL 32807
Recruiting
Eric Carbonell, MD |
|
|
Progressive Medical Research
Port Orange, FL 32127
Recruiting
Alexander White, MD |
|
|
Infinity Clinical Research - Sunrise
Sunrise, FL 33351
Recruiting
Travis St. Pierre |
|
|
Clinical Research of Brandon, LLC (Tampa)
Tampa, FL 33603
Recruiting
Maylin Barrios |
|
|
Stedman Clinical Trials
Tampa, FL 33613
Recruiting
Mary Stedman, MD |
|
|
Premier Research Institute at Palm Beach Neurology
West Palm Beach, FL 33407
Recruiting
Paul Winner, MD |
|
|
Charter Research
Winter Park, FL 32792
Recruiting
Edgardo Rivera, MD |
|
| Idaho | |
|
Velocity Clinical Research, Boise
Meridian, ID 83642
Recruiting
Mark Turner, MD |
|
| Kansas | |
|
Ascension Via Christi Research
Wichita, KS 67214
Recruiting
Paul Murphy, MD |
|
| Louisiana | |
|
Neuro Medical Clinic of Central Louisiana, LLC
Alexandria, LA 71301
Not yet recruiting
Faithe Jordan |
|
| Massachusetts | |
|
Boston Neuro Research Center
North Dartmouth, MA 02747
Recruiting
Mushtaque Chachar, MD |
|
| Missouri | |
|
Clinical Research Professionals
Chesterfield, MO 63005
Recruiting
Amanda Watson |
|
| Nebraska | |
|
CCT Research - Papillion Research Center
Papillion, NE 68046
Recruiting
Kristy Jensen |
|
| New Jersey | |
|
Advanced Clinical Institute, Inc
Neptune, NJ 07753
Recruiting
Mark Ornstein, MD |
|
| New Mexico | |
|
Albuquerque Neuroscience, Inc
Albuquerque, NM 87109
Recruiting
William Summers, MD |
|
| New York | |
|
Dent Neurologic Institute
Amherst, NY 14226
Recruiting
Horacio Capote, MD |
|
|
Mid Hudson Medical Research
New Windsor, NY 12553
Recruiting
Sashi Makam, MD |
|
|
NY Neurology Associates
New York, NY 10003
Recruiting
Artem Kaplan, MD |
|
|
University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
Rochester, NY 14620
Recruiting
Susan Salem-Spencer |
|
|
Five Town Neuroscience Research
Woodmere, NY 11598
Recruiting
David Steiner, MD |
|
| North Carolina | |
|
Triad Clinical Trials, LLC
Greensboro, NC 27410
Recruiting
Richard Montgomery, MD |
|
|
Alzheimer's Memory Center
Matthew, NC 28105
Recruiting
Mohammad Bolouri, MD |
|
| Ohio | |
|
Insight Clinical Trials LLC
Beachwood, OH 44122
Recruiting
Mark Stillman, MD |
|
|
NeuroScience Research Center, LLC
Canton, OH 44718
Recruiting
Shandell Mooney |
|
|
Dayton Center for Neurological Disorders
Centerville, OH 45459
Recruiting
Jon Durrani, MD |
|
| Oregon | |
|
Summit Research Network, LLC
Portland, OR 97210
Not yet recruiting
Annika Truitt |
|
| Pennsylvania | |
|
Lehigh Center for Clinical Research
Allentown, PA 18104
Not yet recruiting
Paul Gross, MD |
|
| Rhode Island | |
|
Rhode Island Mood & Memory Research Institute
East Providence, RI 02914
Recruiting
John Stoukides, MD |
|
| South Carolina | |
|
Ralph H. Johnson VA Health Care System
Charleston, SC 29401
Not yet recruiting
Jacobo Mintzer, MD |
|
|
Palmetto Clinical Research
Summerville, SC 29485
Recruiting
Robert Carlile, MD |
|
| Texas | |
|
Senior Adults Specialty Research, Inc
Austin, TX 78757
Recruiting
Jaron Winston, MD |
|
|
Texas Neurology, PA
Dallas, TX 75206
Recruiting
Michelle Washington, MD |
|
|
Grayline Research Center
Wichita Falls, TX 76309
Recruiting
Benny Barnhart, MD |
|
| Virginia | |
|
Re:Cognition Health
Fairfax, VA 22031
Recruiting
Raymond Scott Turner |
|
| Washington | |
|
Memory and Brain Wellness Center at Harborview
Seattle, WA 98104
Recruiting
Charles Bernick, MD |
|
Who Sponsors This Study?
Lead: Cassava Sciences, Inc.
Collaborator Sponsor
- Premier Research International LLC
Source: ClinicalTrials.gov ID: NCT04994483