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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.
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

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neurological Associates of Albany
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AlbanyUnited StatesUnknown status
Advanced Research Center, Inc.
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AnaheimUnited StatesUnknown status
Emory Alzheimer's Disease Research Center
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AtlantaUnited StatesUnknown status
JEM Research Institute
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AtlantisUnited StatesUnknown status
Northern Light Acadia Hospital
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BangorUnited StatesUnknown status
Insight Clinical Trials LLC
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BeachwoodUnited StatesUnknown status
Great Lakes Clinical Trials- Flourish Research- Chicago
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ChicagoUnited StatesUnknown status
South Lake Pain Institute
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ClermontUnited StatesUnknown status
Prisma Health Neurology
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ColumbiaUnited StatesUnknown status
The Ohio State University -Wexner Medical Center
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ColumbusUnited StatesUnknown status
ATP Clinical Research, Inc.
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Costa MesaUnited StatesUnknown status
Arrow Clinical Trials
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Daytona BeachUnited StatesUnknown status
NeuroStudies
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DecaturUnited StatesUnknown status
Brain Matters Research
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Delray BeachUnited StatesUnknown status
Mile High Research Center
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DenverUnited StatesUnknown status
Velocity Clinical Research, Syracuse
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East SyracuseUnited StatesUnknown status
ReCogniton Health
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FairfaxUnited StatesUnknown status
QUEST Research Institute
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FarmingtonUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest Florida
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Fort MyersUnited StatesUnknown status
North Texas Clinical Trials
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Fort WorthUnited StatesUnknown status
Neurology Center of North Orange County
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FullertonUnited StatesUnknown status
Great Lakes Clinical Trials- Flourish Research- Gurnee
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GurneeUnited StatesUnknown status
Hattiesburg Clinic
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HattiesburgUnited StatesUnknown status
The Clinical Trial Center
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JenkintownUnited StatesUnknown status
University of Tennessee Medical Center
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KnoxvilleUnited StatesUnknown status
Charter Research - Lady Lake
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Lady LakeUnited StatesUnknown status
Multi-Specialty Research Associates, Inc.
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Lake CityUnited StatesUnknown status
Las Vegas Medical Research
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Las VegasUnited StatesUnknown status
Alzheimer's Memory Center - AMC Research
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MatthewsUnited StatesUnknown status
Boston Center for Memory
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NewtonUnited StatesUnknown status
Mid Hudson Medical Research
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New WindsorUnited StatesUnknown status
Coastal Family Medicine - Orange Park
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Orange ParkUnited StatesUnknown status
Emerald Coast Neurology
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PensacolaUnited StatesUnknown status
CCT Research - Foothills Research Center
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PhoenixUnited StatesUnknown status
Barrow Neurological Institute
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PhoenixUnited StatesUnknown status
Office of Donald S. Marks, M.D., P.C.
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PlymouthUnited StatesUnknown status
Quantum Laboratories
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Pompano BeachUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Coastal Neurology
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Port RoyalUnited StatesUnknown status
Wasatch Clinical Research
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Salt Lake CityUnited StatesUnknown status
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
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San AntonioUnited StatesUnknown status
Syrentis Clinical Research
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Santa AnaUnited StatesUnknown status
Intercoastal Medical Group - Sarasota
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SarasotaUnited StatesUnknown status
Office of Elizabeth Zarate-Rowell, MD
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Seal BeachUnited StatesUnknown status
The Cognitive and Research Center of New Jersey
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SpringfieldUnited StatesUnknown status
Sisu BHR, LLC
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SpringfieldUnited StatesUnknown status
TRS Health
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StaffordUnited StatesUnknown status
Suncoast Neuroscience Associates
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St. PetersburgUnited StatesUnknown status
Brain Matters Research (Kane Center)
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StuartUnited StatesUnknown status
Mercury Clinical Research
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Sugar LandUnited StatesUnknown status
Banner Sun Health Research Institute
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Sun CityUnited StatesUnknown status
Charter Research - Winter Park
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Winter ParkUnited StatesUnknown status
Conquest Research
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.