An interventional study of Sensory Stimulation System (GS120) - Active in Alzheimer Disease, Cognitive Impairment and Mild Cognitive Impairment, sponsored by Cognito Therapeutics, Inc.. Enrolling by invitation at 53 sites in United States. Open to participants aged 50 Years to 92 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Cognito Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Initiating or ongoing treatment with any of the following during study participation:
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
All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
Device: Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
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)
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
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)
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
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)
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Plan to share: No
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Cognito Therapeutics, Inc.