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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2022-03-01

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1, Arm A

Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)

Group Type EXPERIMENTAL