ACTIVE_NOT_RECRUITING

A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)

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Conditions

Alzheimer DiseaseAlzheimer Disease 1Alzheimer Disease 2Alzheimer Disease 3Alzheimer Disease, Early OnsetAlzheimer Disease, Late OnsetAlzheimer Disease 9Alzheimer Disease 4Alzheimer Disease 7Alzheimer Disease 17Alzheimer's Dementia Late OnsetAlzheimer Disease 5Alzheimer Disease 6Alzheimer Disease 8Alzheimer Disease 10Alzheimer Disease 11Alzheimer Disease 12Alzheimer Disease 13Alzheimer Disease 14Alzheimer Disease 15Alzheimer Disease 16Alzheimer Disease 18Alzheimer Disease 19DementiaDementia AlzheimersDementia, MildDementia of Alzheimer TypeDementia ModerateDementia SenileMild Cognitive ImpairmentMild DementiaMCICognitive ImpairmentCognitive DeclineCognitive Impairment, MildAlzheimer's DiseaseGamma StimulationCognito

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 670 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).

Official Title

A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)

Quick Facts

Study Start:2022-12-13
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05637801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and Women age 50-90
  2. * Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
  3. * Non-childbearing potential or using adequate birth control
  4. * Mini-Mental State Exam (MMSE) 15-28
  5. * Available/consenting Study Partner
  6. * Able to identify a Legally Authorized Representative (LAR)
  7. * Stable chronic conditions at least 30 days
  8. * Formal education of 8 or more years
  9. * Adequate vision (Able to detect light) and hearing
  10. * Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
  11. * Amyloid or phosphorylated Tau positivity
  1. * Seizure disorder
  2. * Hospitalization in previous 30 days
  3. * Living in continuous care nursing home (assisted living permitted)
  4. * Inability to have an MRI or significant abnormality on MRI screening
  5. * Geriatric Depression Scale (GDS) \>6
  6. * Suicidality (current or previous 6 months)
  7. * Serious neurological diseases affecting the Central Nervous System, including:
  8. 1. other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
  9. 2. neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
  10. 3. serious infection of the brain (meningitis/encephalitis), or
  11. 4. history of multiple concussions.
  12. * Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)
  13. * Schizophrenia or bipolar disorder
  14. * Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
  15. * Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
  16. * Nootropic drugs except stable acetylcholinesterase inhibitors
  17. * Drug or Alcohol abuse in previous 12 months
  18. * Previous exposure to Anti-amyloid-beta vaccines
  19. * Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
  20. * Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
  21. * Involved in a previous Cognito study or gamma therapy study
  22. * Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
  23. * Life expectancy \< 24 months

Contacts and Locations

Principal Investigator

Ralph Kern, MD
PRINCIPAL_INVESTIGATOR
Cognito Therapeutics

Study Locations (Sites)

CCT Research - Gilbert Neurology Partners
Gilbert, Arizona, 85297
United States
Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
CCT Research - Foothills Research Center
Phoenix, Arizona, 85044
United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351
United States
Advanced Research Center, Inc
Anaheim, California, 92805
United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
United States
Neurology Center of North Orange County
Fullerton, California, 92835
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California, 90740
United States
Mile High Research Center
Denver, Colorado, 80218
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
Visionary Investigators Network- Aventura
Aventura, Florida, 33180
United States
South Lake Pain Institute
Clermont, Florida, 34711
United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117
United States
Brain Matters Research
Delray Beach, Florida, 33445
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
United States
Alphab Global Research
Jupiter, Florida, 33458
United States
Charter Research - Lady Lake
Lady Lake, Florida, 32792
United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 23055
United States
Premier Clinical Research Institute Inc.
Miami, Florida, 30033
United States
Visionary Investigators Network- Miami
Miami, Florida, 33133
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
Coastal Family Medicine - Orange Park
Orange Park, Florida, 32073
United States
K2 Medical Research - Orlando
Orlando, Florida, 32806
United States
Emerald Coast Neurology
Pensacola, Florida, 32504
United States
Quantum Laboratories
Pompano Beach, Florida, 33064
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Suncoast Neuroscience Associates
Saint Petersburg, Florida, 33713
United States
Intercoastal Medical Group - Sarasota
Sarasota, Florida, 34239
United States
Brain Matters Research
Stuart, Florida, 34997
United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609
United States
Conquest Research
Winter Park, Florida, 32789
United States
Charter Research - Winter Park
Winter Park, Florida, 32792
United States
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
United States
NeuroStudies
Decatur, Georgia, 30033
United States
Great Lakes Clinical Trials- Flourish Research- Chicago
Chicago, Illinois, 60640
United States
Great Lakes Clinical Trials- Flourish Research- Gurnee
Gurnee, Illinois, 60031
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
United States
Northern Light Acadia Hospital
Bangor, Maine, 04402
United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02131
United States
Boston Center for Memory
Newton, Massachusetts, 02459
United States
Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, 02360
United States
Sisu BHR, LLC
Springfield, Massachusetts, 01103
United States
QUEST Research Institute
Farmington, Michigan, 48334
United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
CCT Research - Papillion Research Center
Papillion, Nebraska, 68046
United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113
United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
United States
Neurological Associates of Albany
Albany, New York, 12208
United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
United States
Mid Hudson Medical Research
New Windsor, New York, 12553
United States
Alzheimer's Memory Center - AMC Research
Matthews, North Carolina, 28105
United States
Insight Clinical Trials, LLC
Beachwood, Ohio, 44122
United States
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Center for Cognitive Health - Portland
Portland, Oregon, 97225
United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046
United States
Prisma Health Neurology
Columbia, South Carolina, 29203
United States
Coastal Neurology
Port Royal, South Carolina, 29935
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
North Texas Clinical Trials
Fort Worth, Texas, 76104
United States
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
San Antonio, Texas, 78229
United States
TRS Health
Stafford, Texas, 77477
United States
Mercury Clinical Research
Sugarland, Texas, 77478
United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107
United States
ReCogniton Health
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Cognito Therapeutics, Inc.

  • Ralph Kern, MD, PRINCIPAL_INVESTIGATOR, Cognito Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Dementia
  • Gamma Stimulation
  • Cognito

Additional Relevant MeSH Terms

  • 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