Alzheimer Disease Clinical Trial
— HopeOfficial title:
A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
NCT number | NCT05637801 |
Other study ID # | CA-0011 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 13, 2022 |
Est. completion date | July 2025 |
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).
Status | Recruiting |
Enrollment | 530 |
Est. completion date | July 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | 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 (ß-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/ |
Country | Name | City | State |
---|---|---|---|
United States | Neurological Associates of Albany | Albany | New York |
United States | Advanced Research Center, Inc | Anaheim | California |
United States | Emory Alzheimer's Disease Research Center | Atlanta | Georgia |
United States | JEM Research Institute | Atlantis | Florida |
United States | Visionary Investigators Network- Aventura | Aventura | Florida |
United States | Northern Light Acadia Hospital | Bangor | Maine |
United States | Insight Clinical Trials, LLC | Beachwood | Ohio |
United States | Boston Clinical Trials, Inc. | Boston | Massachusetts |
United States | Integrative Clinical Trials, LLC | Brooklyn | New York |
United States | Neuro-Behavioral Clinical Research | Canton | Ohio |
United States | Clinical Research Professionals | Chesterfield | Missouri |
United States | Great Lakes Clinical Trials- Flourish Research- Chicago | Chicago | Illinois |
United States | South Lake Pain Institute | Clermont | Florida |
United States | Prisma Health Neurology | Columbia | South Carolina |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | ATP Clinical Research, Inc. | Costa Mesa | California |
United States | Arrow Clinical Trials | Daytona Beach | Florida |
United States | NeuroStudies | Decatur | Georgia |
United States | Brain Matters Research | Delray Beach | Florida |
United States | Mile High Research Center | Denver | Colorado |
United States | Velocity Clinical Research - Syracuse | East Syracuse | New York |
United States | ReCogniton Health | Fairfax | Virginia |
United States | QUEST Research Institute | Farmington | Michigan |
United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
United States | North Texas Clinical Trials | Fort Worth | Texas |
United States | Neurology Center of North Orange County | Fullerton | California |
United States | CCT Research - Gilbert Neurology Partners | Gilbert | Arizona |
United States | Great Lakes Clinical Trials- Flourish Research- Gurnee | Gurnee | Illinois |
United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
United States | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana |
United States | The Clinical Trial Center | Jenkintown | Pennsylvania |
United States | Alphab Global Research | Jupiter | Florida |
United States | University of Tennessee Medical Center | Knoxville | Tennessee |
United States | Charter Research - Lady Lake | Lady Lake | Florida |
United States | Multi-Specialty Research Associates, Inc. | Lake City | Florida |
United States | Las Vegas Medical Research | Las Vegas | Nevada |
United States | Alzheimer's Memory Center - AMC Research | Matthews | North Carolina |
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 | Mid Hudson Medical Research | New Windsor | New York |
United States | Boston Center for Memory | Newton | Massachusetts |
United States | Coastal Family Medicine - Orange Park | Orange Park | Florida |
United States | K2 Medical Research - Orlando | Orlando | Florida |
United States | CCT Research - Papillion Research Center | Papillion | Nebraska |
United States | Emerald Coast Neurology | Pensacola | Florida |
United States | Barrow Neurological Institute | Phoenix | Arizona |
United States | CCT Research - Foothills Research Center | Phoenix | Arizona |
United States | Office of Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts |
United States | Quantum Laboratories | Pompano Beach | Florida |
United States | Progressive Medical Research | Port Orange | Florida |
United States | Coastal Neurology | Port Royal | South Carolina |
United States | Center for Cognitive Health - Portland | Portland | Oregon |
United States | Suncoast Neuroscience Associates | Saint Petersburg | Florida |
United States | Wasatch Clinical Research | Salt Lake City | Utah |
United States | UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases | San Antonio | Texas |
United States | Syrentis Clinical Research | Santa Ana | California |
United States | Intercoastal Medical Group - Sarasota | Sarasota | Florida |
United States | Office of Elizabeth Zarate-Rowell, MD | Seal Beach | California |
United States | Sisu BHR, LLC | Springfield | Massachusetts |
United States | The Cognitive and Research Center of New Jersey | Springfield | New Jersey |
United States | TRS Health | Stafford | Texas |
United States | Brain Matters Research | Stuart | Florida |
United States | Mercury Clinical Research | Sugar Land | Texas |
United States | Banner Sun Health Research Institute | Sun City | Arizona |
United States | Axiom Clinical Research of Florida | Tampa | Florida |
United States | Charter Research - Winter Park | Winter Park | Florida |
United States | Conquest Research | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Cognito Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | |
Primary | 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 | Function and Cognition as measured by CST for ADCS-ADL and MMSE | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | |
Secondary | Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months | Cognition as measured by MMSE | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | |
Secondary | Change from Baseline in Whole brain volume at 12-Months | Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI) | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | |
Secondary | Change from Baseline in Hippocampal volume at 12-Months | Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI) | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | |
Secondary | Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months | Global change in symptoms as measured by CDR | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits |
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