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A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
Sponsor: Cognito Therapeutics, Inc.
Summary
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 670 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).
Official title: A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
670
Start Date
2022-12-13
Completion Date
2026-07
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham settings
Locations (68)
CCT Research - Gilbert Neurology Partners
Gilbert, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
CCT Research - Foothills Research Center
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Advanced Research Center, Inc
Anaheim, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California, United States
Mile High Research Center
Denver, Colorado, United States
JEM Research Institute
Atlantis, Florida, United States
Visionary Investigators Network- Aventura
Aventura, Florida, United States
South Lake Pain Institute
Clermont, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Alphab Global Research
Jupiter, Florida, United States
Charter Research - Lady Lake
Lady Lake, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Premier Clinical Research Institute Inc.
Miami, Florida, United States
Visionary Investigators Network- Miami
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Coastal Family Medicine - Orange Park
Orange Park, Florida, United States
K2 Medical Research - Orlando
Orlando, Florida, United States
Emerald Coast Neurology
Pensacola, Florida, United States
Quantum Laboratories
Pompano Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Intercoastal Medical Group - Sarasota
Sarasota, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Charter Research - Winter Park
Winter Park, Florida, United States
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, United States
NeuroStudies
Decatur, Georgia, United States
Great Lakes Clinical Trials- Flourish Research- Chicago
Chicago, Illinois, United States
Great Lakes Clinical Trials- Flourish Research- Gurnee
Gurnee, Illinois, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Northern Light Acadia Hospital
Bangor, Maine, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, United States
Sisu BHR, LLC
Springfield, Massachusetts, United States
QUEST Research Institute
Farmington, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
CCT Research - Papillion Research Center
Papillion, Nebraska, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Neurological Associates of Albany
Albany, New York, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Alzheimer's Memory Center - AMC Research
Matthews, North Carolina, United States
Insight Clinical Trials, LLC
Beachwood, Ohio, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Center for Cognitive Health - Portland
Portland, Oregon, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Prisma Health Neurology
Columbia, South Carolina, United States
Coastal Neurology
Port Royal, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
San Antonio, Texas, United States
TRS Health
Stafford, Texas, United States
Mercury Clinical Research
Sugarland, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
ReCogniton Health
Fairfax, Virginia, United States