A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study) (HOPE)

A Randomized, Double-blind, Sham-controlled Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (HOPE Study)

This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Impairment; Dementia; Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline; Alzheimer Disease, Early Onset; Alzheimer Disease, Late Onset; MCI; Dementia Alzheimers; Mild Dementia; Dementia of Alzheimer Type; Cognitive Impairment, Mild; Alzheimer Disease 1; Dementia, Mild; Alzheimer Disease 2; Alzheimer Disease 3; Dementia Moderate; 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 Senile
• Intervention / Treatment: Device: Spectris™ AD - Active; Device: Spectris™ AD - Sham

Detailed Description

This is a multicenter, randomized, double-blind, sham-controlled pivotal study.

The objective of this study is to assess the safety and efficacy of gamma sensory stimulation (visual and audio) via Spectris ™ AD in slowing cognitive-functional symptom worsening versus the Sham device for subjects with mild to moderate AD as measured by changes in function and cognition.

Up to approximately six hundred and seventy (670) subjects with Mild to Moderate AD (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Active : Sham). In the Active Group, subjects will be treated with the Active Spectris™ AD for 60 minutes daily. In the Sham Group, subjects are treated with a Sham Spectris™ AD for 60 minutes daily. Daily treatment is planned for approximately 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 subjects enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.

• Study Type: Interventional
• Enrollment (Estimated): 670
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Active Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.	Device: Spectris™ AD - Active; Spectris™ AD - Active settings
Sham Comparator: Sham; Sham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months	Device: Spectris™ AD - Sham; Spectris™ AD - Sham settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)	Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups.	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL	Function as measured by ADCS-ADL	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Mini-Mental State Examination (MMSE)	Cognition as measured by MMSE	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)	Function and cognition as measured by ADCS-iADL	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Collaborators and Investigators

• Sponsor: Cognito Therapeutics, Inc.
• Investigators: Principal Investigator: Robbert Zusterzeel, MD, PhD, MPH, Cognito Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Dementia; Gamma Stimulation; Cognito
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Alzheimer Disease; Lymphoma, Follicular; Dementia; Alzheimer disease type 1; Alzheimer disease, familial, type 3; Alzheimer disease type 4; Alzheimer disease type 2; Alzheimer Disease 9; Alzheimer Disease 7; 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
• Other Study ID Numbers: CA-0011 (JenaValve Technology Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No