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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