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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed for endpoint at screening/baseline and 12-month clinic visits

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