Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
NCT03661034 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-08-24
Summary
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.
Conditions
- 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
Interventions
- DEVICE
-
GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Sponsors & Collaborators
-
Cognito Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Evan R Hempel · Cognito Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2021-05-01
- Completion
- 2022-03-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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