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Alzheimer DiseaseHOPENCT05637801

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

A study testing Spectris™ AD - Active in people with Alzheimer Disease and Alzheimer Disease 1, run by Cognito Therapeutics, Inc. at 68 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
Spectris™ AD - Active
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
673 participants
Where
68 sitesUnited States
Study dates
13 Dec 2022to 17 Aug 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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)
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  • 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
  • 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/

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

United States68 sites

  • Neurological Associates of Albany

    Albany, New York, 12208

  • Advanced Research Center, Inc

    Anaheim, California, 92805

  • Emory Alzheimer's Disease Research Center

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Visionary Investigators Network- Aventura

    Aventura, Florida, 33180

  • Northern Light Acadia Hospital

    Bangor, Maine, 04402

  • Insight Clinical Trials, LLC

    Beachwood, Ohio, 44122

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02131

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • Neuro-Behavioral Clinical Research

    Canton, Ohio, 44720

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Great Lakes Clinical Trials- Flourish Research- Chicago

    Chicago, Illinois, 60640

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • Prisma Health Neurology

    Columbia, South Carolina, 29203

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117

  • NeuroStudies

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • ReCogniton Health

    Fairfax, Virginia, 22031

  • QUEST Research Institute

    Farmington, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • CCT Research - Gilbert Neurology Partners

    Gilbert, Arizona, 85297

  • Great Lakes Clinical Trials- Flourish Research- Gurnee

    Gurnee, Illinois, 60031

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • The Clinical Trial Center

    Jenkintown, Pennsylvania, 19046

  • Alphab Global Research

    Jupiter, Florida, 33458

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Charter Research - Lady Lake

    Lady Lake, Florida, 32792

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 23055

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Alzheimer's Memory Center - AMC Research

    Matthews, North Carolina, 28105

  • Premier Clinical Research Institute Inc.

    Miami, Florida, 30033

  • Visionary Investigators Network- Miami

    Miami, Florida, 33133

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Coastal Family Medicine - Orange Park

    Orange Park, Florida, 32073

  • K2 Medical Research - Orlando

    Orlando, Florida, 32806

  • CCT Research - Papillion Research Center

    Papillion, Nebraska, 68046

  • Emerald Coast Neurology

    Pensacola, Florida, 32504

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • CCT Research - Foothills Research Center

    Phoenix, Arizona, 85044

  • Office of Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Coastal Neurology

    Port Royal, South Carolina, 29935

  • Center for Cognitive Health - Portland

    Portland, Oregon, 97225

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases

    San Antonio, Texas, 78229

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group - Sarasota

    Sarasota, Florida, 34239

  • Office of Elizabeth Zarate-Rowell, MD

    Seal Beach, California, 90740

  • Sisu BHR, LLC

    Springfield, Massachusetts, 01103

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • TRS Health

    Stafford, Texas, 77477

  • Brain Matters Research

    Stuart, Florida, 34997

  • Mercury Clinical Research

    Sugarland, Texas, 77478

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Conquest Research

    Winter Park, Florida, 32789

  • Charter Research - Winter Park

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Spectris™ AD - Active, Spectris™ AD - Sham
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Dementia, Gamma Stimulation, Cognito
Medical subject headings
Alzheimer Disease, Alzheimer disease type 1, Alzheimer disease type 2, Alzheimer disease, familial, type 3, Alzheimer Disease 9, Alzheimer disease type 4, Alzheimer Disease 7, Alzheimer Disease 5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spectris™ AD - ActiveDevice

    Spectris™ AD - Active settings

  • Spectris™ AD - ShamDevice

    Spectris™ AD - Sham settings

Study groups in NCT05637801
Study groupRoleWhat they receive
ActiveExperimentalActive Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
Receives: Device: Spectris™ AD - Active
ShamSham comparatorSham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
Receives: Device: Spectris™ AD - Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Secondary outcomes (3)

  1. Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL

    Function as measured by ADCS-ADL

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

  2. Mini-Mental State Examination (MMSE)

    Cognition as measured by MMSE

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

  3. Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)

    Function and cognition as measured by ADCS-iADL

    Measured: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start13 Dec 2022
  3. Primary completion22 Jun 2026
  4. Study completion17 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-blind, Sham-controlled Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637801
Sponsor's protocol ID
CA-0011
Acronym
HOPE
Status last verified
Sep 2026
First submitted
22 Nov 2022
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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