Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
NCT ID: NCT06245031
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
402 participants
INTERVENTIONAL
2024-02-29
2027-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Interventions
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Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Eligibility Criteria
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Inclusion Criteria
* Non-childbearing potential or using adequate birth control
* Available/consenting Study Partner
Exclusion Criteria
* 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
50 Years
92 Years
ALL
No
Sponsors
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Cognito Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph Kern
Role: PRINCIPAL_INVESTIGATOR
Cognito Therapeutics
Locations
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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
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
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
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 (Kane Center)
Stuart, 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
Northern Light Acadia Hospital
Bangor, Maine, 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
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
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
The Ohio State University Wexner Medical Center
Columbus, Ohio, 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
Sugar Land, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
ReCogniton Health
Fairfax, Virginia, United States
Countries
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Other Identifiers
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CA-0015
Identifier Type: -
Identifier Source: org_study_id
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