Clinical trial NCT06245031: Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
Official title: Open-Label Extension to a Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (OLE Hope Study, CA-0015)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Mild Cognitive Impairment
Dementia, Mild
Dementia Moderate
Dementia Alzheimers
Dementia of Alzheimer Type
AD
Keywords: Gamma Stimulation
Cognito
Lead sponsor: Cognito Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 402
Sex: ALL
Minimum age (years): 50
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an Open-Label Extension of a previous randomized, sham-controlled study. All subjects in this study will receive treatment with a device with Active treatment settings. Analysis is planned to compare Active-Active treatment group to Sham-Active treatment group (delayed start model).
Primary purpose: TREATMENT

Brief summary: This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.

Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

Detailed description: This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group 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).

Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.

Eligibility criteria: Inclusion Criteria:

* Randomized and completed 12-months of participation in the Hope Study (CA-0011)
* Non-childbearing potential or using adequate birth control
* Available/consenting Study Partner

Exclusion Criteria:

* Insufficient adherence to treatment in the Hope Study (CA-0011)
* Living in continuous care nursing home (assisted living permitted)
* Initiating or ongoing treatment with any of the following during study participation:

  * Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
  * Memantine (Namenda or Namzaric)
  * Nootropic drugs except stable acetylcholinesterase inhibitors

For more information about the Hope Study (CA-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/

or the Hope Study ClinicalTrials.gov posting here: https://clinicaltrials.gov/study/NCT05637801

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 a Combined Statistical Test (CST) that creates a composite measure (combining Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) scales into one measure) 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
Other outcomes:
Locations:
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: 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: 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: Orange Park
country: United States
facility: Coastal Family Medicine - Orange Park
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 (Kane Center)
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: Bangor
country: United States
facility: Northern Light Acadia Hospital
state: Maine
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: 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: 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: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
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: Sugar Land
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
role: PRINCIPAL_INVESTIGATOR
References: