Clinical trial NCT05637801: A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: 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
Keywords: Alzheimer's Disease
Mild Cognitive Impairment
Dementia
Gamma Stimulation
Cognito
Lead sponsor: Cognito Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 670
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Secondary objectives will include measures of cognition and neuroanatomical change.

Up to approximately six hundred and seventy (670) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 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 participants enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.

Eligibility criteria: 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/

Primary outcomes:
measure: Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
measure: Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary outcomes:
measure: Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
measure: Change from Baseline in Whole brain volume at 12-Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
measure: Change from Baseline in Hippocampal volume at 12-Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
measure: Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
timeFrame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: CCT Research - Gilbert Neurology Partners
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: CCT Research - Foothills Research Center
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Seal Beach
country: United States
facility: Office of Elizabeth Zarate-Rowell, MD
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network- Aventura
state: Florida
city: Clermont
country: United States
facility: South Lake Pain Institute
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Jupiter
country: United States
facility: Alphab Global Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute Inc.
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network- Miami
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Orange Park
country: United States
facility: Coastal Family Medicine - Orange Park
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - Orlando
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group - Sarasota
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Winter Park
country: United States
facility: Charter Research - Winter Park
state: Florida
city: Atlanta
country: United States
facility: Emory Alzheimer's Disease Research Center
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials- Flourish Research- Chicago
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials- Flourish Research- Gurnee
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Bangor
country: United States
facility: Northern Light Acadia Hospital
state: Maine
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Office of Donald S. Marks, M.D., P.C.
state: Massachusetts
city: Springfield
country: United States
facility: Sisu BHR, LLC
state: Massachusetts
city: Farmington
country: United States
facility: QUEST Research Institute
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Papillion
country: United States
facility: CCT Research - Papillion Research Center
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Matthews
country: United States
facility: Alzheimer's Memory Center - AMC Research
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials, LLC
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Center for Cognitive Health - Portland
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health Neurology
state: South Carolina
city: Port Royal
country: United States
facility: Coastal Neurology
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
state: Texas
city: Stafford
country: United States
facility: TRS Health
state: Texas
city: Sugarland
country: United States
facility: Mercury Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Fairfax
country: United States
facility: ReCogniton Health
state: Virginia
Study officials:
affiliation: Cognito Therapeutics
name: Ralph Kern, MD
role: PRINCIPAL_INVESTIGATOR
References: