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)
1 other identifier
interventional
670
1 country
68
Brief 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. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Dec 2022
Typical duration for not_applicable alzheimer-disease
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMay 5, 2026
April 1, 2026
3.5 years
November 22, 2022
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Outcomes (3)
Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Mini-Mental State Examination (MMSE)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Study Arms (2)
Active
EXPERIMENTALActive Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
Sham
SHAM COMPARATORSham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
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
Intercoastal Medical Group - Sarasota
Sarasota, Florida, 34239, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33713, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robbert Zusterzeel, MD, PhD, MPH
Cognito Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is a double-blind study; the investigator, the subject and study partner, and all other study personnel involved with subject assessments will remain blinded to the actual treatment assignment of the subjects. The Sponsor and their delegates involved in the study will be blinded to actual treatment assignment with the exception of technicians who are necessarily unblinded to assign and maintain the Investigational Devices and data analysis personnel as indicated in the Statistical Analysis Plan (SAP). Technicians and customer service agents who interact with subjects, their study partners and clinical sites will be specially trained to not reveal the study assignment (Active or Sham).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2022
First Posted
December 5, 2022
Study Start
December 13, 2022
Primary Completion
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share