NCT06245031
Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
Enrolling by Invitation
NAAges 50–92InterventionalTreatmentCognito 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
Where it's being run
53 sites across 21 statesFlorida16
California5
Texas4
Arizona3
Massachusetts3
New York3
Georgia2
Illinois2
Study leadership
- Ralph Kern · PRINCIPAL_INVESTIGATOR · Cognito Therapeutics
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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)