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Behavioural Intervention

Active for Mild Cognitive Impairment

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed for endpoint at screening/baseline and 12-month clinic visits
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I completed a year in the Hope Study (CA-0011).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Find a Location

Who is running the clinical trial?

Cognito Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
610 Total Patients Enrolled
Ralph KernPrincipal InvestigatorCognito Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would it be possible for me to participate in this medical study?

"Individuals aged between 50 and 92 years with a diagnosis of Alzheimer's disease are sought for this research study, aiming to enroll approximately 402 participants."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"52 patients are currently being recruited for this research study, with ATP Clinical Research, Inc. in Costa Mesa, Prisma Health Neurology in Columbia, and Neurological Associates of Albany in Albany among the participating sites, alongside 52 other locations."

Answered by AI

Do individuals aged 45 and above meet the criteria for enrollment in this research project?

"Participants must fall within the age range of 50 to 92 years to be considered eligible for enrollment in this clinical trial."

Answered by AI

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"As per the details on clinicaltrials.gov, recruitment for this specific trial is not ongoing. The trial was initially listed on February 1st, 2024 and last revised on February 4th, 2024. Despite this particular study being inactive in terms of participant enrollment, there are currently a total of 1249 other trials actively seeking candidates."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
ReCogniton Health
Recent research and studies
clinicaltrials.govStudy
Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
2024. "Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245031.
~268 spots leftby Aug 2026
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