What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and sensory stimulation systems. Cholinesterase inhibitors can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, and fatigue. Sensory stimulation systems, like the one studied in the trial, are generally well-tolerated, with mild device-associated adverse events reported, including sensations of warmth, numbness, redness, itching, tingling, and muscle spasms. There are no serious adverse events associated with these sensory stimulation systems.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management rather than a cure. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which help increase levels of acetylcholine in the brain, and memantine, an NMDA receptor antagonist that regulates glutamate activity. While these drugs do not involve sensory stimulation, they aim to improve cognitive function and daily living activities. As of now, there are no FDA-approved treatments specifically utilizing sensory stimulation or neuromodulation for Alzheimer's Disease, making the Sensory Stimulation System in the Hope Study a novel approach in this field.

What other types of research exist?

Promising novel alternatives to Sensory Stimulation Systems for Alzheimer's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving cognitive function and is available in the US and UK. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may benefit cognitive function and daily living activities. 3) Vestibular Stimulation, which has been found to be safe and tolerable in AD patients and may improve balance and cognitive function. These alternatives offer non-pharmacologic options that can be discussed with a healthcare provider.

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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 days3 visits

Treatment ~ Varies

Follow Up ~ 28 days1 visit

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and sensory stimulation systems. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, work by increasing cholinergic transmission in the brain, which helps improve cognition and daily functioning by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning. Sensory stimulation systems, like the one being studied in the Hope Study, aim to enhance cognitive function and activities of daily living through targeted sensory inputs. These treatments are crucial for AD patients as they can help manage symptoms, improve quality of life, and maintain independence for as long as possible.