A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
NCT ID: NCT05637801
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
670 participants
INTERVENTIONAL
2022-12-13
2026-07-31
Brief Summary
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Detailed Description
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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.
Up to approximately six hundred and seventy (670) 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Control
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham settings
Interventions
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Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham settings
Eligibility Criteria
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Inclusion Criteria
* 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
* 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/
50 Years
90 Years
ALL
No
Sponsors
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Cognito Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph Kern, MD
Role: PRINCIPAL_INVESTIGATOR
Cognito Therapeutics
Locations
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CCT Research - Gilbert Neurology Partners
Gilbert, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
CCT Research - Foothills Research Center
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Advanced Research Center, Inc
Anaheim, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California, United States
Mile High Research Center
Denver, Colorado, United States
JEM Research Institute
Atlantis, Florida, United States
Visionary Investigators Network- Aventura
Aventura, Florida, United States
South Lake Pain Institute
Clermont, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Alphab Global Research
Jupiter, Florida, United States
Charter Research - Lady Lake
Lady Lake, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Premier Clinical Research Institute Inc.
Miami, Florida, United States
Visionary Investigators Network- Miami
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Coastal Family Medicine - Orange Park
Orange Park, Florida, United States
K2 Medical Research - Orlando
Orlando, Florida, United States
Emerald Coast Neurology
Pensacola, Florida, United States
Quantum Laboratories
Pompano Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Intercoastal Medical Group - Sarasota
Sarasota, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Charter Research - Winter Park
Winter Park, Florida, United States
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, United States
NeuroStudies
Decatur, Georgia, United States
Great Lakes Clinical Trials- Flourish Research- Chicago
Chicago, Illinois, United States
Great Lakes Clinical Trials- Flourish Research- Gurnee
Gurnee, Illinois, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Northern Light Acadia Hospital
Bangor, Maine, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, United States
Sisu BHR, LLC
Springfield, Massachusetts, United States
QUEST Research Institute
Farmington, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
CCT Research - Papillion Research Center
Papillion, Nebraska, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Neurological Associates of Albany
Albany, New York, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Alzheimer's Memory Center - AMC Research
Matthews, North Carolina, United States
Insight Clinical Trials, LLC
Beachwood, Ohio, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Center for Cognitive Health - Portland
Portland, Oregon, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Prisma Health Neurology
Columbia, South Carolina, United States
Coastal Neurology
Port Royal, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
San Antonio, Texas, United States
TRS Health
Stafford, Texas, United States
Mercury Clinical Research
Sugarland, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
ReCogniton Health
Fairfax, Virginia, United States
Countries
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Other Identifiers
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CA-0011
Identifier Type: -
Identifier Source: org_study_id
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