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

Alzheimer Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03661034
Study type Interventional
Source Cognito Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date May 31, 2018
Completion date March 1, 2022
View Details
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