Alzheimer Disease Clinical Trial
Official title:
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)
Verified date | May 2024 |
Source | Cognito Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 402 |
Est. completion date | March 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 92 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Neurological Associates of Albany | Albany | New York |
United States | Advanced Research Center, Inc | Anaheim | California |
United States | Emory Alzheimer's Disease Research Center | Atlanta | Georgia |
United States | JEM Research Institute | Atlantis | Florida |
United States | Northern Light Acadia Hospital | Bangor | Maine |
United States | Insight Clinical Trials, LLC | Beachwood | Ohio |
United States | Great Lakes Clinical Trials- Flourish Research- Chicago | Chicago | Illinois |
United States | South Lake Pain Institute | Clermont | Florida |
United States | Prisma Health Neurology | Columbia | South Carolina |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | ATP Clinical Research, Inc. | Costa Mesa | California |
United States | Arrow Clinical Trials | Daytona Beach | Florida |
United States | NeuroStudies | Decatur | Georgia |
United States | Brain Matters Research | Delray Beach | Florida |
United States | Mile High Research Center | Denver | Colorado |
United States | Velocity Clinical Research - Syracuse | East Syracuse | New York |
United States | ReCogniton Health | Fairfax | Virginia |
United States | QUEST Research Institute | Farmington | Michigan |
United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
United States | North Texas Clinical Trials | Fort Worth | Texas |
United States | Neurology Center of North Orange County | Fullerton | California |
United States | Great Lakes Clinical Trials- Flourish Research- Gurnee | Gurnee | Illinois |
United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
United States | The Clinical Trial Center | Jenkintown | Pennsylvania |
United States | University of Tennessee Medical Center | Knoxville | Tennessee |
United States | Charter Research - Lady Lake | Lady Lake | Florida |
United States | Multi-Specialty Research Associates, Inc. | Lake City | Florida |
United States | Las Vegas Medical Research | Las Vegas | Nevada |
United States | Alzheimer's Memory Center - AMC Research | Matthews | North Carolina |
United States | Mid Hudson Medical Research | New Windsor | New York |
United States | Boston Center for Memory | Newton | Massachusetts |
United States | Coastal Family Medicine - Orange Park | Orange Park | Florida |
United States | Emerald Coast Neurology | Pensacola | Florida |
United States | Barrow Neurological Institute | Phoenix | Arizona |
United States | CCT Research - Foothills Research Center | Phoenix | Arizona |
United States | Office of Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts |
United States | Quantum Laboratories | Pompano Beach | Florida |
United States | Progressive Medical Research | Port Orange | Florida |
United States | Coastal Neurology | Port Royal | South Carolina |
United States | Suncoast Neuroscience Associates | Saint Petersburg | Florida |
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 | Syrentis Clinical Research | Santa Ana | California |
United States | Intercoastal Medical Group - Sarasota | Sarasota | Florida |
United States | Office of Elizabeth Zarate-Rowell, MD | Seal Beach | California |
United States | Sisu BHR, LLC | Springfield | Massachusetts |
United States | The Cognitive and Research Center of New Jersey | Springfield | New Jersey |
United States | TRS Health | Stafford | Texas |
United States | Brain Matters Research (Kane Center) | Stuart | Florida |
United States | Mercury Clinical Research | Sugar Land | Texas |
United States | Banner Sun Health Research Institute | Sun City | Arizona |
United States | Charter Research - Winter Park | Winter Park | Florida |
United States | Conquest Research | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Cognito Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months | Cognition as measured by 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 |
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