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Behavioural Intervention

Sensory Stimulation for Alzheimer's Disease (Hope Trial)

Verified Trial
N/A
Recruiting
Led By J. Tom Megerian, MD
Research Sponsored by Cognito Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is there someone who can accompany you to study clinic visits and answer questions about you symptoms?
Be older than 18 years old
Must not have
Men and Women age 50-85
Non-childbearing potential (females post menopausal or males, if active with females of child bearing potential, willing to use appropriate birth control)
Timeline
Screening 42 days
Treatment Varies
Follow Up 28 days
Awards & highlights

Hope Trial Summary

This trial tests a daily sensory stimulation system to help improve daily activities in people with Alzheimer's. 345 people will be studied for 12 months. Effects will be measured using ADCS-ADL and MMSE tests.

Who is the study for?
This trial is for individuals aged 50-85 with mild to moderate Alzheimer's disease who can attend study visits with someone knowledgeable about their symptoms. They must have stable chronic conditions, adequate vision and hearing, at least 8 years of education, and not be in childbearing potential or agree to use birth control.Check my eligibility
What is being tested?
The Hope Study tests a Sensory Stimulation System (GS120) on people with Alzheimer's. Participants are randomly assigned to receive either the active system or a sham (fake) version daily for 12 months. Their abilities will be assessed using specific activities of daily living and mental state exams.See study design
What are the potential side effects?
Since this trial involves sensory stimulation rather than medication, side effects may include discomfort from wearing the device or possible frustration if there is no improvement in symptoms.

Hope Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have someone who can come with me to clinic visits and talk about my symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am between 50 and 85 years old.
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I am either not able to have children, or I am willing to use birth control.
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My chronic conditions have been stable for at least 30 days.
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You have completed at least 8 years of formal education.
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I can see light and hear sounds.

Hope Trial Timeline

Screening ~ 42 days
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 42 days for screening, Varies for treatment, and 28 days 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 Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
Secondary outcome measures
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
Change from Baseline in Hippocampal volume at 12-Months
Change from Baseline in Whole brain volume at 12-Months
+1 more

Hope Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Group II: ControlPlacebo Group1 Intervention
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

Cognito Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
482 Total Patients Enrolled
J. Tom Megerian, MDPrincipal InvestigatorCognito Therapeutics
Ralph Kern, MDPrincipal InvestigatorCognito Therapeutics

Media Library

Sensory Stimulation System (GS120) - Active (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05637801 — N/A
Alzheimer's Disease Research Study Groups: Active, Control
Alzheimer's Disease Clinical Trial 2023: Sensory Stimulation System (GS120) - Active Highlights & Side Effects. Trial Name: NCT05637801 — N/A
Sensory Stimulation System (GS120) - Active (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05637801 — N/A
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05637801 — N/A

Frequently Asked Questions

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

What is the ideal demographic for participation in this experiment?

"This medical trial is open to 345 individuals between 50 and 85 years of age who have been diagnosed with Alzheimer's disease. Furthermore, they must be able to pass the Mini-Mental State Exam (MMSE) 15-26, demonstrate non-childbearing potential if biologically female or abstain from sexual activity if male with a childbearing partner; possess formal education of 8+ years; show adequate vision and hearing capacity; display mobility capability for compliance with testing procedures (e.g., ambulatory or aided-ambulatory); exhibit stable chronic conditions in the last 30 days; identify an appropriate Legally Authorized Representative (LAR),"

Answered by AI

Is recruitment for this research endeavor still ongoing?

"As indicated by clinicaltrials.gov, this investigation is not presently looking for participants. Posted on December 1st of 2022 and recently modified on the same day, it does not appear that any new applicants are being accepted at this time; however, 1207 other trials are recruiting patients now."

Answered by AI

What are the aims of this investigative research?

"The primary target of this clinical trial, monitored over the duration of a 12-month period, is to assess and evaluate changes in Alzheimer's disease Cooperative Study - Activities of Daily Living (ADCS-ADL). Secondary objectives include tracking modifications from Baseline in Hippocampal volume through 3T Magnetic Resonance Imaging (MRI), Clinical Dementia Rating- Sum of Boxes (CDR-SB) for global symptom change, and Mini Mental State Exam (MMSE) for cognitive progression."

Answered by AI

Is this research study allowing individuals of advanced age to take part?

"This trial's enrollment requirements state that the minimum age for participants is 50, while the highest allowable age is 85."

Answered by AI

How many locales are currently running this clinical experiment?

"At this time, 10 clinical trial sites across the country are seeking patients for participation. These locations include Brooklyn, Stuart and Winter Park as well as seven other areas; selecting a clinic closest to you can reduce your travel needs if you choose to join the study."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
Office of Donald S. Marks, M.D., P.C.
MedStar Georgetown University Hospital
TRS Health
Other

Why did patients apply to this trial?

I would like to slow my Alzheimer's. I want to help find a cure for Alzhemer disease.
PatientReceived 2+ prior treatments
My father and mother had dementia My sister had alzheimer’s. I have tried one medication and it didn’t work for me very well.
PatientReceived 2+ prior treatments
Hoping to find help and hope to slow the progression of this disease.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How soon may I begin? How long do screening visits take? This will take over an hour to drive to/ how long and how many visits are involved?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Neurology Center of North Orange County: < 48 hours
  2. TRS Health: < 48 hours
Typically responds via
Email
Phone Call
~216 spots leftby Mar 2025