Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

Alzheimer Disease Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06245031
• Other study ID #: CA-0015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: Cognito Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 402
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 92 Years

Eligibility

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

Related Conditions & MeSH terms

• AD
• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia Alzheimers
• Dementia Moderate
• Dementia of Alzheimer Type
• Dementia, Mild
• Mild Cognitive Impairment

Intervention

Device:
• Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings

Locations

Country	Name	City	State
United States	Neurological Associates of Albany	Albany	New York
United States	Advanced Research Center, Inc	Anaheim	California
United States	Emory Alzheimer's Disease Research Center	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	Northern Light Acadia Hospital	Bangor	Maine
United States	Insight Clinical Trials, LLC	Beachwood	Ohio
United States	Great Lakes Clinical Trials- Flourish Research- Chicago	Chicago	Illinois
United States	South Lake Pain Institute	Clermont	Florida
United States	Prisma Health Neurology	Columbia	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	Arrow Clinical Trials	Daytona Beach	Florida
United States	NeuroStudies	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Mile High Research Center	Denver	Colorado
United States	Velocity Clinical Research - Syracuse	East Syracuse	New York
United States	ReCogniton Health	Fairfax	Virginia
United States	QUEST Research Institute	Farmington	Michigan
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	North Texas Clinical Trials	Fort Worth	Texas
United States	Neurology Center of North Orange County	Fullerton	California
United States	Great Lakes Clinical Trials- Flourish Research- Gurnee	Gurnee	Illinois
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Charter Research - Lady Lake	Lady Lake	Florida
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Alzheimer's Memory Center - AMC Research	Matthews	North Carolina
United States	Mid Hudson Medical Research	New Windsor	New York
United States	Boston Center for Memory	Newton	Massachusetts
United States	Coastal Family Medicine - Orange Park	Orange Park	Florida
United States	Emerald Coast Neurology	Pensacola	Florida
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	CCT Research - Foothills Research Center	Phoenix	Arizona
United States	Office of Donald S. Marks, M.D., P.C.	Plymouth	Massachusetts
United States	Quantum Laboratories	Pompano Beach	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Coastal Neurology	Port Royal	South Carolina
United States	Suncoast Neuroscience Associates	Saint Petersburg	Florida
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases	San Antonio	Texas
United States	Syrentis Clinical Research	Santa Ana	California
United States	Intercoastal Medical Group - Sarasota	Sarasota	Florida
United States	Office of Elizabeth Zarate-Rowell, MD	Seal Beach	California
United States	Sisu BHR, LLC	Springfield	Massachusetts
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	TRS Health	Stafford	Texas
United States	Brain Matters Research (Kane Center)	Stuart	Florida
United States	Mercury Clinical Research	Sugar Land	Texas
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Charter Research - Winter Park	Winter Park	Florida
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cognito Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months	Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Primary	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	Function and Cognition as measured by CST of ADCS-ADL and MMSE (ADCS-ADL total score possible from 0-78, where a lower score is more affected by Alzheimer's disease) (MMSE total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary	Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months	Cognition as measured by MMSE (total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits