A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011) (Hope)

April 22, 2024 updated by: Cognito Therapeutics, Inc.

A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)

This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Approximately 530 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham 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). Secondary objectives will include measures of cognition and neuroanatomical change.

Five-hundred and thirty (530) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 12 months.

Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up).

Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select participants enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.

Study Type

Interventional

Enrollment (Estimated)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Terminated
        • CCT Research - Gilbert Neurology Partners
      • Phoenix, Arizona, United States, 85013
      • Phoenix, Arizona, United States, 85044
        • Recruiting
        • CCT Research - Foothills Research Center
        • Contact:
      • Sun City, Arizona, United States, 85351
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc
        • Contact:
      • Costa Mesa, California, United States, 92626
        • Terminated
        • ATP Clinical Research, Inc.
      • Fullerton, California, United States, 92835
        • Recruiting
        • Neurology Center of North Orange County
        • Contact:
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
        • Contact:
      • Seal Beach, California, United States, 90740
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Mile High Research Center
        • Contact:
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute
        • Contact:
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Visionary Investigators Network- Aventura
        • Contact:
      • Clermont, Florida, United States, 34711
        • Recruiting
        • South Lake Pain Institute
        • Contact:
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
        • Contact:
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Brain Matters Research
        • Contact:
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Neuropsychiatric Research Center of Southwest Florida
        • Contact:
      • Jupiter, Florida, United States, 33458
        • Terminated
        • Alphab Global Research
      • Lady Lake, Florida, United States, 32792
      • Lake City, Florida, United States, 23055
        • Recruiting
        • Multi-Specialty Research Associates, Inc.
        • Contact:
      • Miami, Florida, United States, 30033
        • Terminated
        • Premier Clinical Research Institute Inc.
      • Miami, Florida, United States, 33133
        • Recruiting
        • Visionary Investigators Network- Miami
        • Contact:
      • Naples, Florida, United States, 34105
      • Orange Park, Florida, United States, 32073
        • Recruiting
        • Coastal Family Medicine - Orange Park
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • K2 Medical Research - Orlando
        • Contact:
      • Pensacola, Florida, United States, 32504
      • Pompano Beach, Florida, United States, 33064
      • Port Orange, Florida, United States, 32127
      • Saint Petersburg, Florida, United States, 33713
      • Sarasota, Florida, United States, 34239
      • Stuart, Florida, United States, 34997
        • Recruiting
        • Brain Matters Research
        • Contact:
      • Tampa, Florida, United States, 33609
      • Winter Park, Florida, United States, 32789
      • Winter Park, Florida, United States, 32792
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory Alzheimer's Disease Research Center
        • Contact:
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials- Flourish Research- Chicago
        • Contact:
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Great Lakes Clinical Trials- Flourish Research- Gurnee
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Terminated
        • Josephson Wallack Munshower Neurology, PC
    • Maine
      • Bangor, Maine, United States, 04402
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Terminated
        • Boston Clinical Trials, Inc.
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory
        • Contact:
      • Plymouth, Massachusetts, United States, 02360
        • Recruiting
        • Office of Donald S. Marks, M.D., P.C.
        • Contact:
      • Springfield, Massachusetts, United States, 01103
    • Michigan
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
    • Missouri
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Terminated
        • CCT Research - Papillion Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Medical Research
        • Contact:
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • The Cognitive and Research Center of New Jersey
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Neurological Associates of Albany
        • Contact:
      • Brooklyn, New York, United States, 11229
        • Terminated
        • Integrative Clinical Trials, LLC
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Velocity Clinical Research - Syracuse
        • Contact:
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research
        • Contact:
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Alzheimer's Memory Center - AMC Research
        • Contact:
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
    • South Carolina
      • Columbia, South Carolina, United States, 29203
      • Port Royal, South Carolina, United States, 29935
        • Recruiting
        • Coastal Neurology
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • North Texas Clinical Trials
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
        • Contact:
      • Stafford, Texas, United States, 77477
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Mercury Clinical Research
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Wasatch Clinical Research
        • Contact:
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and Women age 50-90
  • Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
  • Non-childbearing potential or using adequate birth control
  • Mini-Mental State Exam (MMSE) 15-28
  • Available/consenting Study Partner
  • Able to identify a Legally Authorized Representative (LAR)
  • Stable chronic conditions at least 30 days
  • Formal education of 8 or more years
  • Adequate vision (Able to detect light) and hearing
  • Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
  • Amyloid or phosphorylated Tau positivity

Exclusion Criteria:

  • Seizure disorder
  • Hospitalization in previous 30 days
  • Living in continuous care nursing home (assisted living permitted)
  • Inability to have an MRI or significant abnormality on MRI screening
  • Geriatric Depression Scale (GDS) >6
  • Suicidality (current or previous 6 months)

  • Serious neurological diseases affecting the Central Nervous System, including:

    1. other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
    2. neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
    3. serious infection of the brain (meningitis/encephalitis), or
    4. history of multiple concussions.
  • Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)
  • Schizophrenia or bipolar disorder
  • Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
  • Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
  • Nootropic drugs except stable acetylcholinesterase inhibitors
  • Drug or Alcohol abuse in previous 12 months
  • Previous exposure to Anti-amyloid-beta vaccines
  • Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
  • Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
  • Involved in a previous Cognito study or gamma therapy study
  • Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
  • Life expectancy < 24 months

Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.

For more information visit: https://www.hopestudyforad.com/

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Device: Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Sham Comparator: Control
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
Device: Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham 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
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function as measured by the ADCS-ADL
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function and Cognition as measured by CST for ADCS-ADL and MMSE
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
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Cognition as measured by MMSE
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Change from Baseline in Whole brain volume at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Change from Baseline in Hippocampal volume at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Global change in symptoms as measured by CDR
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cognito Therapeutics, Inc.

Investigators

  • Principal Investigator: Ralph Kern, MD, Cognito Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-0011 (JenaValve Technology Inc.)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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