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

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).

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, Mild
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Related 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, Mild

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Gilbert

CCT Research - Gilbert Neurology Partners, Gilbert, Arizona, United States, 85297

Phoenix

Barrow Neurological Institute, Phoenix, Arizona, United States, 85013

Phoenix

CCT Research - Foothills Research Center, Phoenix, Arizona, United States, 85044

Sun City

Banner Sun Health Research Institute, Sun City, Arizona, United States, 85351

Anaheim

Advanced Research Center, Inc, Anaheim, California, United States, 92805

Costa Mesa

ATP Clinical Research, Inc., Costa Mesa, California, United States, 92626

Fullerton

Neurology Center of North Orange County, Fullerton, California, United States, 92835

Santa Ana

Syrentis Clinical Research, Santa Ana, California, United States, 92705

Seal Beach

Office of Elizabeth Zarate-Rowell, MD, Seal Beach, California, United States, 90740

Denver

Mile High Research Center, Denver, Colorado, United States, 80218

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cognito Therapeutics, Inc.,

Ralph Kern, MD, PRINCIPAL_INVESTIGATOR, Cognito Therapeutics

Study Record Dates

2026-07