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NCT06245031

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

Enrolling by Invitation
NAAges 50–92InterventionalTreatment
Cognito Therapeutics, Inc.
~402 participants
Updated 2024-05-07 on ClinicalTrials.gov
What's tested:Sensory Stimulation System (GS120) - Active

At a glance

Recruiting sites
0 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Measured over Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
+1 more outcome measured

Conditions

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

Explore related trials

Alzheimer's DiseaseCognitive DysfunctionMild cognitive disorderMild dementiaModerate dementia

NCT06245031

Where you'd take part

This study runs at 53 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Research Center, Inc

    Anaheim, Californiano site contact published

  • Alzheimer's Memory Center - AMC Research

    Matthews, North Carolinano site contact published

  • Arrow Clinical Trials

    Daytona Beach, Floridano site contact published

  • ATP Clinical Research, Inc.

    Costa Mesa, Californiano site contact published

  • Banner Sun Health Research Institute

    Sun City, Arizonano site contact published

  • Barrow Neurological Institute

    Phoenix, Arizonano site contact published

  • Boston Center for Memory

    Newton, Massachusettsno site contact published

  • Brain Matters Research

    Delray Beach, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ralph Kern · PRINCIPAL_INVESTIGATOR · Cognito Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-MonthsAssessed for endpoint at Screening/Baseline and 12-Month clinic visits

    Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)

  • Change from Baseline in a Combined Statistical Test (CST) that creates a composite measure (combining Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) scales into one measure) at 12-MonthsAssessed for endpoint at Screening/Baseline and 12-Month clinic visits

    Function and Cognition as measured by CST of ADCS-ADL and MMSE (ADCS-ADL total score possible from 0-78, where a lower score is more affected by Alzheimer's disease) (MMSE total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)