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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06245031
Other study ID # CA-0015
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 29, 2024
Est. completion date March 2027

Study information

Verified date May 2024
Source Cognito Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites. The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 402
Est. completion date March 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years to 92 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Intervention

Device:
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings

Locations

Country Name City State
United States Neurological Associates of Albany Albany New York
United States Advanced Research Center, Inc Anaheim California
United States Emory Alzheimer's Disease Research Center Atlanta Georgia
United States JEM Research Institute Atlantis Florida
United States Northern Light Acadia Hospital Bangor Maine
United States Insight Clinical Trials, LLC Beachwood Ohio
United States Great Lakes Clinical Trials- Flourish Research- Chicago Chicago Illinois
United States South Lake Pain Institute Clermont Florida
United States Prisma Health Neurology Columbia South Carolina
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States ATP Clinical Research, Inc. Costa Mesa California
United States Arrow Clinical Trials Daytona Beach Florida
United States NeuroStudies Decatur Georgia
United States Brain Matters Research Delray Beach Florida
United States Mile High Research Center Denver Colorado
United States Velocity Clinical Research - Syracuse East Syracuse New York
United States ReCogniton Health Fairfax Virginia
United States QUEST Research Institute Farmington Michigan
United States Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida
United States North Texas Clinical Trials Fort Worth Texas
United States Neurology Center of North Orange County Fullerton California
United States Great Lakes Clinical Trials- Flourish Research- Gurnee Gurnee Illinois
United States Hattiesburg Clinic Hattiesburg Mississippi
United States The Clinical Trial Center Jenkintown Pennsylvania
United States University of Tennessee Medical Center Knoxville Tennessee
United States Charter Research - Lady Lake Lady Lake Florida
United States Multi-Specialty Research Associates, Inc. Lake City Florida
United States Las Vegas Medical Research Las Vegas Nevada
United States Alzheimer's Memory Center - AMC Research Matthews North Carolina
United States Mid Hudson Medical Research New Windsor New York
United States Boston Center for Memory Newton Massachusetts
United States Coastal Family Medicine - Orange Park Orange Park Florida
United States Emerald Coast Neurology Pensacola Florida
United States Barrow Neurological Institute Phoenix Arizona
United States CCT Research - Foothills Research Center Phoenix Arizona
United States Office of Donald S. Marks, M.D., P.C. Plymouth Massachusetts
United States Quantum Laboratories Pompano Beach Florida
United States Progressive Medical Research Port Orange Florida
United States Coastal Neurology Port Royal South Carolina
United States Suncoast Neuroscience Associates Saint Petersburg Florida
United States Wasatch Clinical Research Salt Lake City Utah
United States UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases San Antonio Texas
United States Syrentis Clinical Research Santa Ana California
United States Intercoastal Medical Group - Sarasota Sarasota Florida
United States Office of Elizabeth Zarate-Rowell, MD Seal Beach California
United States Sisu BHR, LLC Springfield Massachusetts
United States The Cognitive and Research Center of New Jersey Springfield New Jersey
United States TRS Health Stafford Texas
United States Brain Matters Research (Kane Center) Stuart Florida
United States Mercury Clinical Research Sugar Land Texas
United States Banner Sun Health Research Institute Sun City Arizona
United States Charter Research - Winter Park Winter Park Florida
United States Conquest Research Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Cognito Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease) Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Primary 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-Months 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) Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months Cognition as measured by MMSE (total score possible from 0-30, where a lower score is more affected by Alzheimer's disease) Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
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