NCT06245031Enrolling by invitation
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)
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 402 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- 29 Feb 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Cognito Therapeutics, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT06245031
What you commit to
- Study type: Interventional
- Planned participants: 402
- From 29 Feb 2024 to the primary completion date, Dec 2026
- 53 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Insufficient adherence to treatment in the Hope Study (CA-0011)
- Living in continuous care nursing home (assisted living permitted)
Who the study is looking for
- 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
Age in the registry: 50 years to 92 years · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurological Associates of Albany Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Advanced Research Center, Inc. Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Emory Alzheimer's Disease Research Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| JEM Research Institute Coordinator of this site? Confirm its status | Atlantis | United States | Unknown status |
| Northern Light Acadia Hospital Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Insight Clinical Trials LLC Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| Great Lakes Clinical Trials- Flourish Research- Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| South Lake Pain Institute Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Prisma Health Neurology Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| ATP Clinical Research, Inc. Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Arrow Clinical Trials Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| NeuroStudies Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Brain Matters Research Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Mile High Research Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Velocity Clinical Research, Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| ReCogniton Health Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Neuropsychiatric Research Center of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| North Texas Clinical Trials Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Neurology Center of North Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Great Lakes Clinical Trials- Flourish Research- Gurnee Coordinator of this site? Confirm its status | Gurnee | United States | Unknown status |
| Hattiesburg Clinic Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| The Clinical Trial Center Coordinator of this site? Confirm its status | Jenkintown | United States | Unknown status |
| University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Charter Research - Lady Lake Coordinator of this site? Confirm its status | Lady Lake | United States | Unknown status |
| Multi-Specialty Research Associates, Inc. Coordinator of this site? Confirm its status | Lake City | United States | Unknown status |
| Las Vegas Medical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Alzheimer's Memory Center - AMC Research Coordinator of this site? Confirm its status | Matthews | United States | Unknown status |
| Boston Center for Memory Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Mid Hudson Medical Research Coordinator of this site? Confirm its status | New Windsor | United States | Unknown status |
| Coastal Family Medicine - Orange Park Coordinator of this site? Confirm its status | Orange Park | United States | Unknown status |
| Emerald Coast Neurology Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| CCT Research - Foothills Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Office of Donald S. Marks, M.D., P.C. Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Quantum Laboratories Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Coastal Neurology Coordinator of this site? Confirm its status | Port Royal | United States | Unknown status |
| Wasatch Clinical Research Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Syrentis Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Intercoastal Medical Group - Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Office of Elizabeth Zarate-Rowell, MD Coordinator of this site? Confirm its status | Seal Beach | United States | Unknown status |
| The Cognitive and Research Center of New Jersey Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Sisu BHR, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| TRS Health Coordinator of this site? Confirm its status | Stafford | United States | Unknown status |
| Suncoast Neuroscience Associates Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Brain Matters Research (Kane Center) Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| Mercury Clinical Research Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Banner Sun Health Research Institute Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Charter Research - Winter Park Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.