Sensory Stimulation for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+52 other locations

Overseen byRalph Kern

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cognito Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ralph Kern

Principal Investigator

Cognito Therapeutics

Eligibility Criteria

This trial is for individuals who have completed the Hope Study (CA-0011) and are dealing with various stages of Alzheimer's or cognitive impairment. They should be willing to use an Active Sensory Stimulation System daily.

Inclusion Criteria

Available/consenting Study Partner

Non-childbearing potential or using adequate birth control

I completed a year in the Hope Study (CA-0011).

Exclusion Criteria

I am starting or currently on Memantine treatment.

Insufficient adherence to treatment in the Hope Study (CA-0011)

I am starting or currently receiving immune therapy for Alzheimer's disease.

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Treatment Details

Interventions

Sensory Stimulation System (GS120) (Behavioural Intervention)

Trial OverviewParticipants will use the Active Sensory Stimulation System (GS120) for one hour each day over a period of up to 12 months. This study aims to see if this treatment can help improve symptoms related to Alzheimer's and cognitive decline.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.