Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

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.

Interventions

• Sensory Stimulation System (GS120) - Active · DEVICE

  Sensory Stimulation System (GS120) - Active settings

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (53)

• Barrow Neurological Institute, Phoenix, Arizona
• CCT Research - Foothills Research Center, Phoenix, Arizona
• Banner Sun Health Research Institute, Sun City, Arizona
• Advanced Research Center, Inc, Anaheim, California
• ATP Clinical Research, Inc., Costa Mesa, California
• Neurology Center of North Orange County, Fullerton, California
• Syrentis Clinical Research, Santa Ana, California
• Office of Elizabeth Zarate-Rowell, MD, Seal Beach, California
• Mile High Research Center, Denver, Colorado
• JEM Research Institute, Atlantis, Florida
• South Lake Pain Institute, Clermont, Florida
• Arrow Clinical Trials, Daytona Beach, Florida
• Brain Matters Research, Delray Beach, Florida
• Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida
• Charter Research - Lady Lake, Lady Lake, Florida
• Multi-Specialty Research Associates, Inc., Lake City, Florida
• Coastal Family Medicine - Orange Park, Orange Park, Florida
• Emerald Coast Neurology, Pensacola, Florida
• Quantum Laboratories, Pompano Beach, Florida
• Progressive Medical Research, Port Orange, Florida
• Intercoastal Medical Group - Sarasota, Sarasota, Florida
• Suncoast Neuroscience Associates, St. Petersburg, Florida
• Brain Matters Research (Kane Center), Stuart, Florida
• Conquest Research, Winter Park, Florida
• Charter Research - Winter Park, Winter Park, Florida
• Emory Alzheimer's Disease Research Center, Atlanta, Georgia
• NeuroStudies, Decatur, Georgia
• Great Lakes Clinical Trials- Flourish Research- Chicago, Chicago, Illinois
• Great Lakes Clinical Trials- Flourish Research- Gurnee, Gurnee, Illinois
• Northern Light Acadia Hospital, Bangor, Maine
• Boston Center for Memory, Newton, Massachusetts
• Office of Donald S. Marks, M.D., P.C., Plymouth, Massachusetts
• Sisu BHR, LLC, Springfield, Massachusetts
• QUEST Research Institute, Farmington, Michigan
• Hattiesburg Clinic, Hattiesburg, Mississippi
• Las Vegas Medical Research, Las Vegas, Nevada
• The Cognitive and Research Center of New Jersey, Springfield, New Jersey
• Neurological Associates of Albany, Albany, New York
• Velocity Clinical Research - Syracuse, East Syracuse, New York
• Mid Hudson Medical Research, New Windsor, New York
• Alzheimer's Memory Center - AMC Research, Matthews, North Carolina
• Insight Clinical Trials, LLC, Beachwood, Ohio
• The Ohio State University Wexner Medical Center, Columbus, Ohio
• The Clinical Trial Center, Jenkintown, Pennsylvania
• Prisma Health Neurology, Columbia, South Carolina
• Coastal Neurology, Port Royal, South Carolina
• University of Tennessee Medical Center, Knoxville, Tennessee
• North Texas Clinical Trials, Fort Worth, Texas
• UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases, San Antonio, Texas
• TRS Health, Stafford, Texas
• Mercury Clinical Research, Sugar Land, Texas
• Wasatch Clinical Research, Salt Lake City, Utah
• ReCogniton Health, Fairfax, Virginia