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Alzheimer DiseaseNCT06245031

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

A study testing Sensory Stimulation System (GS120) - Active in people with Alzheimer Disease and Cognitive Impairment, run by Cognito Therapeutics, Inc. at 53 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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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). Read more about this study

Who is it for?
Ages 50 to 92 years
What is being tested?
Sensory Stimulation System (GS120) - Active
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
53 sitesUnited States
Study dates
29 Feb 2024to Mar 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 92 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

53 sites in 1 country. Contact the study team or a site near you to ask about taking part.

53 sites in 1 country

United States53 sites

  • Neurological Associates of Albany

    Albany, New York, 12208

  • Advanced Research Center, Inc

    Anaheim, California, 92805

  • Emory Alzheimer's Disease Research Center

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Northern Light Acadia Hospital

    Bangor, Maine, 04402

  • Insight Clinical Trials, LLC

    Beachwood, Ohio, 44122

  • Great Lakes Clinical Trials- Flourish Research- Chicago

    Chicago, Illinois, 60640

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • Prisma Health Neurology

    Columbia, South Carolina, 29203

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117

  • NeuroStudies

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • ReCogniton Health

    Fairfax, Virginia, 22031

  • QUEST Research Institute

    Farmington, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Great Lakes Clinical Trials- Flourish Research- Gurnee

    Gurnee, Illinois, 60031

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • The Clinical Trial Center

    Jenkintown, Pennsylvania, 19046

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Charter Research - Lady Lake

    Lady Lake, Florida, 32792

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 23055

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Alzheimer's Memory Center - AMC Research

    Matthews, North Carolina, 28105

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Coastal Family Medicine - Orange Park

    Orange Park, Florida, 32073

  • Emerald Coast Neurology

    Pensacola, Florida, 32504

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • CCT Research - Foothills Research Center

    Phoenix, Arizona, 85044

  • Office of Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Coastal Neurology

    Port Royal, South Carolina, 29935

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases

    San Antonio, Texas, 78229

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group - Sarasota

    Sarasota, Florida, 34239

  • Office of Elizabeth Zarate-Rowell, MD

    Seal Beach, California, 90740

  • Sisu BHR, LLC

    Springfield, Massachusetts, 01103

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • TRS Health

    Stafford, Texas, 77477

  • Brain Matters Research (Kane Center)

    Stuart, Florida, 34997

  • Mercury Clinical Research

    Sugar Land, Texas, 77478

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Conquest Research

    Winter Park, Florida, 32789

  • Charter Research - Winter Park

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Sensory Stimulation System (GS120) - Active
Keywords
Gamma Stimulation, Cognito
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Stimulation System (GS120) - ActiveDevice

    Sensory Stimulation System (GS120) - Active settings

Study groups in NCT06245031
Study groupRoleWhat they receive
ActiveExperimentalAll subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
Receives: Device: Sensory Stimulation System (GS120) - Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

  2. 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)

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Secondary outcomes (1)

  1. 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)

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start29 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an Open-Label Extension of a previous randomized, sham-controlled study. All subjects in this study will receive treatment with a device with Active treatment settings. Analysis is planned to compare Active-Active treatment group to Sham-Active treatment group (delayed start model).
Masking
None (open label)
Enrolment
402 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245031
Sponsor's protocol ID
CA-0015
Status last verified
May 2024
First submitted
26 Jan 2024
Last updated
7 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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