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Dose Response Study of Simufilam for Mild-to-Moderate Alzheimer's Disease (REFOCUS-ALZ)

Start: November 18, 2021
End: June 2024
Enrollment: 1083

What Is This Study About?

This Phase 3 clinical trial, named REFOCUS-ALZ, will test the safety and effects of different dosing levels of the experimental drug simufilam 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 50 mg or 100 mg tablets of simufilam or a placebo, twice daily for 76 weeks. Participants will attend clinic visits for evaluation four weeks after the start of the study, 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. In addition, some locations may also collect brain scans, using MRI or PET imaging. 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 scan 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 > 35
  • Currently taking aducanumab
  • COVID-19 infection within three months of study screening. If no history of a prior COVID-19 infection, must be fully vaccinated for COVID-19 at least two weeks prior to start of 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?

Banner Alzheimer's Institute
Phoenix, AZ 85006
Po-Heng Tsai, MD
Clinical Endpoints
Scottsdale, AZ 85258
Allan Block, MD
Banner Sun Health Research Institute
Sun City, AZ 85351
Danielle Goldfarb, MD
Banner Alzheimer's Institute - Tucson
Tucson, AZ 85718
Joshua Sipes
North County Neurology Associates
Carlsbad, CA 92011
Estela Soto
Neuro-Pain Medical Center
Fresno, CA 93710
Perminder Bhatia, MD
Neurology Center of North Orange County
Fullerton, CA 92835
Johnson Moon, MD
California Research Insitute
Los Angeles, CA 90027
Not yet recruiting
Nelson Owyoung, MD
Shankle Clinic and Hoag Memorial Hospital Presbyterian
Newport Beach, CA 92663
William Shankle, MD
Pacific Research Network, LLC
San Diego, CA 92103
Stephen Thein, PhD
University of California - San Francisco: Memory and Aging Center
San Francisco, CA 94158
Lawren VandeVrede, MD
Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC
Danbury, CT 06810
Dawn Marie Morsey
Ki Health Partners, LLC
Stamford, CT 06905
Not yet recruiting
Valerija Misev
JEM Research Institute
Atlantis, FL 33462
Mark Goldstein, MD
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, FL 33486
Not yet recruiting
Mariana Carvalho
Clinical Research of Brandon, LLC
Brandon, FL 33511
Maylin Barrios
Brain Matters Research Inc
Delray Beach, FL 33445
Paayal Patel, MD
Indago Research and Health Center, Inc.
Hialeah, FL 33012
Evelio Sosa, MD
Mind Institute at Miami Jewish Health
Miami, FL 33137
Alex Gomez
Brainstorm Research
Miami, FL 33176
Not yet recruiting
Brad Herskowitz
Health Synergy Clinical Research
Okeechobee, FL 34972
Not yet recruiting
Marina Winberg
Medical Research Group of Central Florida
Orange City, FL 32763
Not yet recruiting
Adly Thebaud
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, FL 32801
Joan Cutillo
Quantum Laboratories
Pompano Beach, FL 33064
Karen Herr
Intercoastal Medical Group - Sarasota
Sarasota, FL 34239
Mauricio Concha, MD
Alzheimer's Research & Treatment Center
Stuart, FL 34997
Jennifer Lipofsky, MD
Brain Matters Research Inc
Stuart, FL 34997
Paayal Patel, MD
USF Health - Byrd Alzheimer's Center and Research Institute
Tampa, FL 33613
Breanna Davis
Alzheimer's Research & Treatment Center
Wellington, FL 33414
Sydney Werner, MD
Conquest Research
Winter Park, FL 32789
Melissa O'Neill
Columbus Memory Center, PC
Columbus, GA 31909
Jonathan Liss, MD
Accel Research Sites - NeuroStudies
Decatur, GA 30030
Adrienne Hilliard
Great Lakes Clinical Trials
Chicago, IL 60640
Not yet recruiting
Kimberly Potocki
ActivMed Practices & Research, LLC
Methuen, MA 01844
Not yet recruiting
Alfaurys Rosario
Boston Center for Memory
Newton, MA 02459
Not yet recruiting
Paul Solomon, PhD
Office of Donald S. Marks, M.D., P.C.
Plymouth, MA 02360
Not yet recruiting
Elaine Kearney
MedVadis Research
Waltham, MA 02451
Donald Counihan
New Jersey
Global Medical Institutes, LLC
Princeton, NJ 08540
James Wolberg, MD
The Cognitive and Research Center of New Jersey (CRCNJ)
Springfield, NJ 07081
Jessica Tabman
Advanced Memory Research Institute of NJ
Toms River, NJ 08755
Sanjiv Sharma, MD
Neurology Specialists of Monmouth County
West Long Branch, NJ 07764
Noah Gilson, MD
New York
Albany Medical Center
Albany, NY 12208
Not yet recruiting
David Hart, MD
Neurological Associates of Albany
Albany, NY 12208
Richard Holub, MD
Integrative Clinical Trials
Brooklyn, NY 11229
Michael Yuryev, DO
SPRI Clinical Trials Brooklyn
Brooklyn, NY 11235
Not yet recruiting
Tatyana Tsiporin
Clarity Clinical Research
East Syracuse, NY 13057
Robert Cupelo, MD
Richmond Behavioral Associates
Staten Island, NY 10312
Mark DiBuono, MD
Ohio State University
Columbus, OH 43210
Douglas Scharre, MD
Neurology Diagnostics
Dayton, OH 45459
Joel Vandersluis, MD
Neuro-Behavioral Clinical Research (NBCR)
North Canton, OH 44720
Not yet recruiting
Shishuka Malhotra, MD
Center for Cognitive Health - Portland
Portland, OR 97225
Ericka Eyton
The Clinical Trial Center
Jenkintown, PA 19046
Marvin Kalafer, MD
Keystone Clinical Studies, LLC
Plymouth Meeting, PA 19462
Cherian Verghese, MD
KCA Neurology, PLLC
Franklin, TN 37067
Not yet recruiting
Gretchen Campbell, MD
Neurology Consultants of Dallas, PA
Dallas, TX 75243
J. Christina Howell
The Memory Clinic - Bennington
Bennington, VT 05201
Guy deBros
Northwest Clinical Research Center
Bellevue, WA 98007
Rachel Hall
Medical College of Wisconsin
Milwaukee, WI 53226
Malgorzata Franczak, MD

Who Sponsors This Study?

Lead: Cassava Sciences, Inc.

Collaborator Sponsor

  • Premier Research International LLC

Source: ID: NCT05026177