A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
Purpose
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).
Conditions
- Alzheimer Disease
- Alzheimer Disease 1
- Alzheimer Disease 2
- Alzheimer Disease 3
- Alzheimer Disease, Early Onset
- Alzheimer Disease, Late Onset
- Alzheimer Disease 9
- Alzheimer Disease 4
- Alzheimer Disease 7
- Alzheimer Disease 17
- Alzheimer's Dementia Late Onset
- Alzheimer Disease 5
- Alzheimer Disease 6
- Alzheimer Disease 8
- Alzheimer Disease 10
- Alzheimer Disease 11
- Alzheimer Disease 12
- Alzheimer Disease 13
- Alzheimer Disease 14
- Alzheimer Disease 15
- Alzheimer Disease 16
- Alzheimer Disease 18
- Alzheimer Disease 19
- Dementia
- Dementia Alzheimers
- Dementia, Mild
- Dementia of Alzheimer Type
- Dementia Moderate
- Dementia Senile
- Mild Cognitive Impairment
- Mild Dementia
- MCI
- Cognitive Impairment
- Cognitive Decline
- Cognitive Impairment, Mild
Eligibility
- Eligible Ages
- Between 50 Years and 90 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- This is a double-blind study; the investigator, the subject and study partner, and all other study personnel involved with subject assessments will remain blinded to the actual treatment assignment of the subjects. The Sponsor and their delegates involved in the study will be blinded to actual treatment assignment with the exception of technicians who are necessarily unblinded to assign and maintain the Investigational Devices and data analysis personnel as indicated in the Statistical Analysis Plan (SAP). Technicians and customer service agents who interact with subjects, their study partners and clinical sites will be specially trained to not reveal the study assignment (Active or Sham).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active |
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months. |
|
|
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. |
|
Recruiting Locations
Barrow Neurological Institute
Phoenix, Arizona 85013
Phoenix, Arizona 85013
CCT Research - Foothills Research Center
Phoenix, Arizona 85044
Phoenix, Arizona 85044
Banner Sun Health Research Institute
Sun City, Arizona 85351
Sun City, Arizona 85351
Advanced Research Center, Inc
Anaheim, California 92805
Anaheim, California 92805
Neurology Center of North Orange County
Fullerton, California 92835
Fullerton, California 92835
Syrentis Clinical Research
Santa Ana, California 92705
Santa Ana, California 92705
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California 90740
Seal Beach, California 90740
Mile High Research Center
Denver, Colorado 80218
Denver, Colorado 80218
JEM Research Institute
Atlantis, Florida 33462
Atlantis, Florida 33462
Visionary Investigators Network- Aventura
Aventura, Florida 33180
Aventura, Florida 33180
South Lake Pain Institute
Clermont, Florida 34711
Clermont, Florida 34711
Arrow Clinical Trials
Daytona Beach, Florida 32117
Daytona Beach, Florida 32117
Brain Matters Research
Delray Beach, Florida 33445
Delray Beach, Florida 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Fort Myers, Florida 33912
Charter Research - Lady Lake
Lady Lake, Florida 32792
Lady Lake, Florida 32792
Multi-Specialty Research Associates, Inc.
Lake City, Florida 23055
Lake City, Florida 23055
Visionary Investigators Network- Miami
Miami, Florida 33133
Miami, Florida 33133
Aqualane Clinical Research
Naples, Florida 34105
Naples, Florida 34105
Coastal Family Medicine - Orange Park
Orange Park, Florida 32073
Orange Park, Florida 32073
K2 Medical Research - Orlando
Orlando, Florida 32806
Orlando, Florida 32806
Emerald Coast Neurology
Pensacola, Florida 32504
Pensacola, Florida 32504
Quantum Laboratories
Pompano Beach, Florida 33064
Pompano Beach, Florida 33064
Progressive Medical Research
Port Orange, Florida 32127
Port Orange, Florida 32127
Suncoast Neuroscience Associates
Saint Petersburg, Florida 33713
Saint Petersburg, Florida 33713
Intercoastal Medical Group - Sarasota
Sarasota, Florida 34239
Sarasota, Florida 34239
Brain Matters Research
Stuart, Florida 34997
Stuart, Florida 34997
Axiom Clinical Research of Florida
Tampa, Florida 33609
Tampa, Florida 33609
Conquest Research
Winter Park, Florida 32789
Winter Park, Florida 32789
Charter Research - Winter Park
Winter Park, Florida 32792
Winter Park, Florida 32792
Emory Alzheimer's Disease Research Center
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Great Lakes Clinical Trials- Flourish Research- Chicago
Chicago, Illinois 60640
Chicago, Illinois 60640
Great Lakes Clinical Trials- Flourish Research- Gurnee
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Northern Light Acadia Hospital
Bangor, Maine 04402
Bangor, Maine 04402
Boston Center for Memory
Newton, Massachusetts 02459
Newton, Massachusetts 02459
Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts 02360
Plymouth, Massachusetts 02360
Sisu BHR, LLC
Springfield, Massachusetts 01103
Springfield, Massachusetts 01103
QUEST Research Institute
Farmington, Michigan 48334
Farmington, Michigan 48334
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
Hattiesburg, Mississippi 39401
Clinical Research Professionals
Chesterfield, Missouri 63005
Chesterfield, Missouri 63005
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
Springfield, New Jersey 07081
Neurological Associates of Albany
Albany, New York 12208
Albany, New York 12208
Velocity Clinical Research - Syracuse
East Syracuse, New York 13057
East Syracuse, New York 13057
Alzheimer's Memory Center - AMC Research
Matthews, North Carolina 28105
Matthews, North Carolina 28105
Insight Clinical Trials, LLC
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Neuro-Behavioral Clinical Research
Canton, Ohio 44720
Canton, Ohio 44720
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Center for Cognitive Health - Portland
Portland, Oregon 97225
Portland, Oregon 97225
Coastal Neurology
Port Royal, South Carolina 29935
Port Royal, South Carolina 29935
North Texas Clinical Trials
Fort Worth, Texas 76104
Fort Worth, Texas 76104
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
San Antonio, Texas 78229
San Antonio, Texas 78229
Mercury Clinical Research
Sugarland, Texas 77478
Sugarland, Texas 77478
Wasatch Clinical Research
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
More Details
- NCT ID
- NCT05637801
- Status
- Recruiting
- Sponsor
- Cognito Therapeutics, Inc.
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.