Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
Open-Label Extension to a Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (OLE Hope Study, CA-0015)
1 other identifier
interventional
402
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Feb 2024
Typical duration for not_applicable alzheimer-disease
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedStudy Start
First participant enrolled
February 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 7, 2024
May 1, 2024
2.8 years
January 26, 2024
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
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
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)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Outcomes (1)
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
Study Arms (1)
Active
EXPERIMENTALAll subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
Interventions
Sensory Stimulation System (GS120) - Active settings
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
CCT Research - Foothills Research Center
Phoenix, Arizona, 85044, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Advanced Research Center, Inc
Anaheim, California, 92805, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California, 90740, United States
Mile High Research Center
Denver, Colorado, 80218, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
South Lake Pain Institute
Clermont, Florida, 34711, United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Charter Research - Lady Lake
Lady Lake, Florida, 32792, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 23055, United States
Coastal Family Medicine - Orange Park
Orange Park, Florida, 32073, United States
Emerald Coast Neurology
Pensacola, Florida, 32504, United States
Quantum Laboratories
Pompano Beach, Florida, 33064, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Intercoastal Medical Group - Sarasota
Sarasota, Florida, 34239, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33713, United States
Brain Matters Research (Kane Center)
Stuart, Florida, 34997, United States
Conquest Research
Winter Park, Florida, 32789, United States
Charter Research - Winter Park
Winter Park, Florida, 32792, United States
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, 30329, United States
NeuroStudies
Decatur, Georgia, 30033, United States
Great Lakes Clinical Trials- Flourish Research- Chicago
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials- Flourish Research- Gurnee
Gurnee, Illinois, 60031, United States
Northern Light Acadia Hospital
Bangor, Maine, 04402, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, 02360, United States
Sisu BHR, LLC
Springfield, Massachusetts, 01103, United States
QUEST Research Institute
Farmington, Michigan, 48334, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Neurological Associates of Albany
Albany, New York, 12208, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
Alzheimer's Memory Center - AMC Research
Matthews, North Carolina, 28105, United States
Insight Clinical Trials, LLC
Beachwood, Ohio, 44122, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Prisma Health Neurology
Columbia, South Carolina, 29203, United States
Coastal Neurology
Port Royal, South Carolina, 29935, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
San Antonio, Texas, 78229, United States
TRS Health
Stafford, Texas, 77477, United States
Mercury Clinical Research
Sugar Land, Texas, 77478, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
ReCogniton Health
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Kern
Cognito Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2024
First Posted
February 7, 2024
Study Start
February 29, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
May 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share