Multi-Center Study of Sensory Stimulation to Improve Brain Function

Study Overview
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Brief Summary
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The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

Detailed Description
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The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older. Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Official Title
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Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)

Conditions
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Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mild, Dementia, Alzheimer Type, Dementia of Alzheimer Type, Dementia, Cognitive Impairment, Mild, Cognitive Decline

Intervention / Treatment
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* Device: GammaSense Stimulation System (Active Settings)
* Device: GammaSense Stimulation System (Sham Settings)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 55 Years old MMSE 14-26 Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD Participation of a caregiver 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: 55 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Will use the Active GammaSense Stimulation System. | Device: GammaSense Stimulation System (Active Settings)<br>* Proprietary auditory and visual sensory stimulation device.<br>|
| Sham Comparator: Control Group<br>Will use the Sham GammaSense Stimulation System. | Device: GammaSense Stimulation System (Sham Settings)<br>* Proprietary auditory and visual sensory stimulation device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment | Quarterly over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid PET/CT |  | Quarterly over 6 months | 

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