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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Cognito Therapeutics, Inc.
Study ID
NCT06245031
Status
Enrolling By Invitation

Conditions

  • AD
  • Alzheimer Disease
  • Cognitive Impairment
  • Dementia Alzheimers
  • Dementia Moderate
  • Dementia of Alzheimer Type
  • Dementia, Mild
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 92 Years
Healthy Volunteers
Not accepted

Interventions

  • Sensory Stimulation System (GS120) - Active — DEVICE
    Sensory Stimulation System (GS120) - Active settings

Study Details

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 Dates

Start date
Feb 29, 2024
Status verified
May 2024
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
402 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.

Primary Outcome Measure

Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]

Locations (53)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013-
CCT Research - Foothills Research CenterPhoenixArizona85044-
Banner Sun Health Research InstituteSun CityArizona85351-
Advanced Research Center, IncAnaheimCalifornia92805-
ATP Clinical Research, Inc.Costa MesaCalifornia92626-
Neurology Center of North Orange CountyFullertonCalifornia92835-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
Office of Elizabeth Zarate-Rowell, MDSeal BeachCalifornia90740-
Mile High Research CenterDenverColorado80218-
JEM Research InstituteAtlantisFlorida33462-
South Lake Pain InstituteClermontFlorida34711-
Arrow Clinical TrialsDaytona BeachFlorida32117-
Brain Matters ResearchDelray BeachFlorida33445-
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912-
Charter Research - Lady LakeLady LakeFlorida32792-
Multi-Specialty Research Associates, Inc.Lake CityFlorida23055-
Coastal Family Medicine - Orange ParkOrange ParkFlorida32073-
Emerald Coast NeurologyPensacolaFlorida32504-
Quantum LaboratoriesPompano BeachFlorida33064-
Progressive Medical ResearchPort OrangeFlorida32127-
Intercoastal Medical Group - SarasotaSarasotaFlorida34239-
Suncoast Neuroscience AssociatesSt. PetersburgFlorida33713-
Brain Matters Research (Kane Center)StuartFlorida34997-
Charter Research - Winter ParkWinter ParkFlorida32792-
Conquest ResearchWinter ParkFlorida32789-
Emory Alzheimer's Disease Research CenterAtlantaGeorgia30329-
NeuroStudiesDecaturGeorgia30033-
Great Lakes Clinical Trials- Flourish Research- ChicagoChicagoIllinois60640-
Great Lakes Clinical Trials- Flourish Research- GurneeGurneeIllinois60031-
Northern Light Acadia HospitalBangorMaine04402-
Boston Center for MemoryNewtonMassachusetts02459-
Office of Donald S. Marks, M.D., P.C.PlymouthMassachusetts02360-
Sisu BHR, LLCSpringfieldMassachusetts01103-
QUEST Research InstituteFarmingtonMichigan48334-
Hattiesburg ClinicHattiesburgMississippi39401-
Las Vegas Medical ResearchLas VegasNevada89113-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
Neurological Associates of AlbanyAlbanyNew York12208-
Velocity Clinical Research - SyracuseEast SyracuseNew York13057-
Mid Hudson Medical ResearchNew WindsorNew York12553-
Alzheimer's Memory Center - AMC ResearchMatthewsNorth Carolina28105-
Insight Clinical Trials, LLCBeachwoodOhio44122-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
The Clinical Trial CenterJenkintownPennsylvania19046-
Prisma Health NeurologyColumbiaSouth Carolina29203-
Coastal NeurologyPort RoyalSouth Carolina29935-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
North Texas Clinical TrialsFort WorthTexas76104-
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative DiseasesSan AntonioTexas78229-
TRS HealthStaffordTexas77477-
Mercury Clinical ResearchSugar LandTexas77478-
Wasatch Clinical ResearchSalt Lake CityUtah84107-
ReCogniton HealthFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Barrow Neurological Institute· Phoenix, AZCCT Research - Foothills Research Center· Phoenix, AZBanner Sun Health Research Institute· Sun City, AZAdvanced Research Center, Inc· Anaheim, CAATP Clinical Research, Inc.· Costa Mesa, CANeurology Center of North Orange County· Fullerton, CA

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