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

Not Applicable

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; AD; Dementia Moderate; Dementia Alzheimers; Dementia of Alzheimer Type; Cognitive Impairment; Dementia, Mild

• Registration Number: NCT06245031
• Lead Sponsor: Cognito Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-02-04
• Study First Posted: 2024-02-07
• Study Start: 2024-02-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits	Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)
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	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits	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)

Secondary Outcome Measures

Name	Time	Method
Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months	Assessed for endpoint at Screening/Baseline and 12-Month clinic visits	Cognition as measured by MMSE (total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)

Trial Locations

Locations (53)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

CCT Research - Foothills Research Center; 🇺🇸 Phoenix, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Advanced Research Center, Inc; 🇺🇸 Anaheim, California, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

Office of Elizabeth Zarate-Rowell, MD; 🇺🇸 Seal Beach, California, United States

Mile High Research Center; 🇺🇸 Denver, Colorado, United States

JEM Research Institute; 🇺🇸 Atlantis, Florida, United States

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