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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia, Mild, Dementia Moderate, Dementia Alzheimers, Dementia of Alzheimer Type, AD

In brief

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.

Key facts

Study ID

NCT06245031

Run by

Cognito Therapeutics, Inc.

People needed

402

Starts

2024-02-29

Expected to finish

2027-03-01

Last updated by the study team

2024-05-07

Who can join

Age: 50 and older, up to 92. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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