A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011) (Hope)
Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Mild Cognitive Impairment, Dementia
Eligibility Criteria
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: 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 Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 6 months prior to consent or during study 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 For more information visit: https://www.hopestudyforad.com/
Sites / Locations
- CCT Research - Gilbert Neurology PartnersRecruiting
- Barrow Neurological InstituteRecruiting
- CCT Research - Foothills Research CenterRecruiting
- Banner Sun Health Research InstituteRecruiting
- Advanced Research Center, IncRecruiting
- ATP Clinical Research, Inc.Recruiting
- Neurology Center of North Orange CountyRecruiting
- Syrentis Clinical ResearchRecruiting
- Office of Elizabeth Zarate-Rowell, MDRecruiting
- Mile High Research CenterRecruiting
- JEM Research InstituteRecruiting
- South Lake Pain InstituteRecruiting
- Arrow Clinical TrialsRecruiting
- Brain Matters ResearchRecruiting
- Neuropsychiatric Research Center of Southwest FloridaRecruiting
- Alphab Global Research
- Charter Research - Lady LakeRecruiting
- Multi-Specialty Research Associates, Inc.Recruiting
- Premier Clinical Research Institute Inc.
- Coastal Family Medicine - Orange ParkRecruiting
- Emerald Coast NeurologyRecruiting
- Quantum LaboratoriesRecruiting
- Progressive Medical ResearchRecruiting
- Suncoast Neuroscience AssociatesRecruiting
- Intercoastal Medical Group - SarasotaRecruiting
- Brain Matters ResearchRecruiting
- Conquest ResearchRecruiting
- Charter Research - Winter ParkRecruiting
- Emory Alzheimer's Disease Research Center
- NeuroStudiesRecruiting
- Great Lakes Clinical Trials- Flourish Research- ChicagoRecruiting
- Great Lakes Clinical Trials- Flourish Research- GurneeRecruiting
- Josephson Wallack Munshower Neurology, PC
- Northern Light Acadia HospitalRecruiting
- Boston Clinical Trials, Inc.
- Boston Center for MemoryRecruiting
- Office of Donald S. Marks, M.D., P.C.Recruiting
- Sisu BHR, LLCRecruiting
- QUEST Research InstituteRecruiting
- Hattiesburg ClinicRecruiting
- CCT Research - Papillion Research CenterRecruiting
- Las Vegas Medical ResearchRecruiting
- The Cognitive and Research Center of New JerseyRecruiting
- Neurological Associates of AlbanyRecruiting
- Integrative Clinical Trials, LLC
- Velocity Clinical Research - SyracuseRecruiting
- Mid Hudson Medical ResearchRecruiting
- Alzheimer's Memory Center - AMC ResearchRecruiting
- Insight Clinical Trials, LLCRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- The Clinical Trial CenterRecruiting
- Prisma Health NeurologyRecruiting
- Coastal NeurologyRecruiting
- University of Tennessee Medical Center
- North Texas Clinical TrialsRecruiting
- UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative DiseasesRecruiting
- TRS HealthRecruiting
- Mercury Clinical ResearchRecruiting
- Wasatch Clinical ResearchRecruiting
- ReCogniton Health
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active
Control
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.