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Behavioural Intervention

Sensory Stimulation for Alzheimer's Disease

N/A
Waitlist Available
Led By Ralph Kern
Research Sponsored by Cognito Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Randomized and completed 12-months of participation in the Hope Study (CA-0011)
Be older than 18 years old
Must not have
Initiating or ongoing treatment with Memantine (Namenda or Namzaric)
Initiating or ongoing treatment with immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed for endpoint at screening/baseline and 12-month clinic visits
Awards & highlights

Summary

This trial is an extension of a previous study where participants will receive treatment with an Active Sensory Stimulation System for up to 12 months. There will be no sham treatment or randomization in this

Who is the study for?
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.
What is being tested?
Participants 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.
What are the potential side effects?
Since the intervention involves sensory stimulation, potential side effects may include discomfort or other sensations during the stimulation process, but specific side effects are not detailed in this summary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed a year in the Hope Study (CA-0011).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am starting or currently on Memantine treatment.
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I am starting or currently receiving immune therapy for Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed for endpoint at screening/baseline and 12-month clinic visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed for endpoint at screening/baseline and 12-month clinic visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
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
Secondary study objectives
Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months

Trial Design

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.

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Who is running the clinical trial?

Cognito Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
610 Total Patients Enrolled
Ralph KernPrincipal InvestigatorCognito Therapeutics
~268 spots leftby Dec 2026
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