Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

Study Overview
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Brief Summary
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The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

Detailed Description
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Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Official Title
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Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

Conditions
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Memory Loss, Alzheimer Dementia, Alzheimer Disease, Early Onset, Alzheimer Disease, Mild Cognitive Impairment, Memory Disorders, Memory Impairment, Memory Disorders, Age Related, Alzheimer Disease, Late Onset, Cognitive Impairment, Dementia, Mild, Dementia, Alzheimer Type, Cognitive Decline

Intervention / Treatment
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* Device: GammaSense Stimulation System (non-invasive, non-significant risk)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 50 Years Old MMSE 24 - 30 Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD Participation of a caregiver / care partner Amyloid Positive PET Scan Exclusion Criteria: Profound hearing or visual impairment Seizure Disorder Use of memantine (Namenda or Namzaric) Implantable devices (non-MR compatible)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1, Arm A<br>Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk) | Device: GammaSense Stimulation System (non-invasive, non-significant risk)<br>* Non-invasive, non-significant risk audio-visual sensory stimulation device<br>* Other names: FG-0003;|
| Experimental: Cohort 1, Arm B<br>Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk) | Device: GammaSense Stimulation System (non-invasive, non-significant risk)<br>* Non-invasive, non-significant risk audio-visual sensory stimulation device<br>* Other names: FG-0003;|
| Experimental: Cohort 2, Arm C<br>Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) | Device: GammaSense Stimulation System (non-invasive, non-significant risk)<br>* Non-invasive, non-significant risk audio-visual sensory stimulation device<br>* Other names: FG-0003;|
| Experimental: Cohort 2, Arm D<br>Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) | Device: GammaSense Stimulation System (non-invasive, non-significant risk)<br>* Non-invasive, non-significant risk audio-visual sensory stimulation device<br>* Other names: FG-0003;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Amyloid Positron Emission Tomography (PET) Scan | Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions | PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month) | 
| Adverse Events | Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points). | Over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption. | Baseline, 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer's Disease, Memory Loss