Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
- Conditions
- Alzheimer DiseaseMild Cognitive ImpairmentADDementia ModerateDementia AlzheimersDementia of Alzheimer TypeCognitive ImpairmentDementia, Mild
- Interventions
- Device: Sensory Stimulation System (GS120) - Active
- Registration Number
- NCT06245031
- Lead Sponsor
- Cognito Therapeutics, Inc.
- Brief Summary
This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.
Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
- Detailed Description
This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites.
The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE).
Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 402
- Randomized and completed 12-months of participation in the Hope Study (CA-0011)
- Non-childbearing potential or using adequate birth control
- Available/consenting Study Partner
-
Insufficient adherence to treatment in the Hope Study (CA-0011)
-
Living in continuous care nursing home (assisted living permitted)
-
Initiating or ongoing treatment with any of the following during study participation:
- Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
- Memantine (Namenda or Namzaric)
- Nootropic drugs except stable acetylcholinesterase inhibitors
For more information about the Hope Study (CA-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/
or the Hope Study ClinicalTrials.gov posting here: https://clinicaltrials.gov/study/NCT05637801
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Sensory Stimulation System (GS120) - Active All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
- Primary Outcome Measures
Name Time Method Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)
Change from Baseline in a Combined Statistical Test (CST) that creates a composite measure (combining Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) scales into one measure) at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Function and Cognition as measured by CST of ADCS-ADL and MMSE (ADCS-ADL total score possible from 0-78, where a lower score is more affected by Alzheimer's disease) (MMSE total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)
- Secondary Outcome Measures
Name Time Method Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Cognition as measured by MMSE (total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)
Trial Locations
- Locations (53)
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
NeuroStudies
🇺🇸Decatur, Georgia, United States
Northern Light Acadia Hospital
🇺🇸Bangor, Maine, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Velocity Clinical Research - Syracuse
🇺🇸East Syracuse, New York, United States
Prisma Health Neurology
🇺🇸Columbia, South Carolina, United States
ReCogniton Health
🇺🇸Fairfax, Virginia, United States
Emory Alzheimer's Disease Research Center
🇺🇸Atlanta, Georgia, United States
Great Lakes Clinical Trials- Flourish Research- Chicago
🇺🇸Chicago, Illinois, United States
Brain Matters Research (Kane Center)
🇺🇸Stuart, Florida, United States
TRS Health
🇺🇸Stafford, Texas, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
CCT Research - Foothills Research Center
🇺🇸Phoenix, Arizona, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
🇺🇸San Antonio, Texas, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Advanced Research Center, Inc
🇺🇸Anaheim, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Office of Elizabeth Zarate-Rowell, MD
🇺🇸Seal Beach, California, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
Charter Research - Lady Lake
🇺🇸Lady Lake, Florida, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Coastal Family Medicine - Orange Park
🇺🇸Orange Park, Florida, United States
Emerald Coast Neurology
🇺🇸Pensacola, Florida, United States
Quantum Laboratories
🇺🇸Pompano Beach, Florida, United States
Intercoastal Medical Group - Sarasota
🇺🇸Sarasota, Florida, United States
Suncoast Neuroscience Associates
🇺🇸Saint Petersburg, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Charter Research - Winter Park
🇺🇸Winter Park, Florida, United States
QUEST Research Institute
🇺🇸Farmington, Michigan, United States
Great Lakes Clinical Trials- Flourish Research- Gurnee
🇺🇸Gurnee, Illinois, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Sisu BHR, LLC
🇺🇸Springfield, Massachusetts, United States
Office of Donald S. Marks, M.D., P.C.
🇺🇸Plymouth, Massachusetts, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
Mid Hudson Medical Research
🇺🇸New Windsor, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Alzheimer's Memory Center - AMC Research
🇺🇸Matthews, North Carolina, United States
Insight Clinical Trials, LLC
🇺🇸Beachwood, Ohio, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Coastal Neurology
🇺🇸Port Royal, South Carolina, United States
Mercury Clinical Research
🇺🇸Sugar Land, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States