A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
- Conditions
- Alzheimer Disease 2Alzheimer Disease 17Alzheimer's Dementia Late OnsetAlzheimer Disease 1Alzheimer Disease 6Alzheimer Disease 10Alzheimer Disease 13Dementia of Alzheimer TypeDementia ModerateDementia Senile
- Interventions
- Device: Sensory Stimulation System (GS120) - ActiveDevice: Sensory Stimulation System (GS120) - Sham
- Registration Number
- NCT05637801
- Lead Sponsor
- Cognito Therapeutics, Inc.
- Brief Summary
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 600 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).
- 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.
Up to approximately six hundred (600) 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
-
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:
- other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
- neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
- serious infection of the brain (meningitis/encephalitis), or
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Sensory Stimulation System (GS120) - Active Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months. Control Sensory Stimulation System (GS120) - Sham Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
- Primary Outcome Measures
Name Time Method 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 Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Function and Cognition as measured by CST for ADCS-ADL and MMSE
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Function as measured by the ADCS-ADL
- Secondary Outcome Measures
Name Time Method Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Cognition as measured by MMSE
Change from Baseline in Whole brain volume at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Change from Baseline in Hippocampal volume at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months Assessed for endpoint at Screening/Baseline and 12-Month clinic visits Global change in symptoms as measured by CDR
Trial Locations
- Locations (67)
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
🇺🇸Stuart, 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
Suncoast Neuroscience Associates
🇺🇸Saint Petersburg, Florida, United States
Intercoastal Medical Group - Sarasota
🇺🇸Sarasota, 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