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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cognitive Impairment; Alzheimer Disease; Mild Cognitive Impairment; Dementia Alzheimers; Dementia of Alzheimer Type; AD; Dementia, Mild; Dementia Moderate
• Intervention / Treatment: Device: Sensory Stimulation System (GS120) - Active

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Phoenix, Arizona, United States, 85044
      • CCT Research - Foothills Research Center
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Seal Beach, California, United States, 90740
      • Office of Elizabeth Zarate-Rowell, MD
  • Colorado
    • Denver, Colorado, United States, 80218
      • Mile High Research Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Clermont, Florida, United States, 34711
      • South Lake Pain Institute
    • Daytona Beach, Florida, United States, 32117
      • Arrow Clinical Trials
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Lady Lake, Florida, United States, 32792
      • Charter Research - Lady Lake
    • Lake City, Florida, United States, 23055
      • Multi-Specialty Research Associates, Inc.
    • Orange Park, Florida, United States, 32073
      • Coastal Family Medicine - Orange Park
    • Pensacola, Florida, United States, 32504
      • Emerald Coast Neurology
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Saint Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience Associates
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group - Sarasota
    • Stuart, Florida, United States, 34997
      • Brain Matters Research (Kane Center)
    • Winter Park, Florida, United States, 32789
      • Conquest Research
    • Winter Park, Florida, United States, 32792
      • Charter Research - Winter Park
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Alzheimer's Disease Research Center
    • Decatur, Georgia, United States, 30033
      • NeuroStudies
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials- Flourish Research- Chicago
    • Gurnee, Illinois, United States, 60031
      • Great Lakes Clinical Trials- Flourish Research- Gurnee
  • Maine
    • Bangor, Maine, United States, 04402
      • Northern Light Acadia Hospital
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Plymouth, Massachusetts, United States, 02360
      • Office of Donald S. Marks, M.D., P.C.
    • Springfield, Massachusetts, United States, 01103
      • Sisu BHR, LLC
  • Michigan
    • Farmington, Michigan, United States, 48334
      • Quest Research Institute
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • New Jersey
    • Springfield, New Jersey, United States, 07081
      • The Cognitive and Research Center of New Jersey
  • New York
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research - Syracuse
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research
  • North Carolina
    • Matthews, North Carolina, United States, 28105
      • Alzheimer's Memory Center - AMC Research
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Insight Clinical Trials, LLC
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical CEnter
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health Neurology
    • Port Royal, South Carolina, United States, 29935
      • Coastal Neurology
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
    • Stafford, Texas, United States, 77477
      • TRS Health
    • Sugar Land, Texas, United States, 77478
      • Mercury Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • ReCogniton Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.	Device: Sensory Stimulation System (GS120) - Active; Sensory Stimulation System (GS120) - Active settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cognito Therapeutics, Inc.
• Investigators: Principal Investigator: Ralph Kern, Cognito Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Gamma Stimulation; Cognito
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: CA-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No