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

  • STATUS
    Not Recruiting
  • participants needed
    20
  • sponsor
    Cognito Therapeutics, Inc.
Updated on 22 January 2021
cognitive impairment
pet scan
positron emission tomography
mini-mental state examination
alzheimer's disease
mild cognitive impairment
amyloid
amyloidosis
mmse
sensory stimulation

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.

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.

Details
Condition Amnesia, Memory impairment, Alzheimer's Disease, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline, Alzheimer Dementia, Dementia, Mild, Memory Loss
Treatment GammaSense Stimulation System (non-invasive, non-significant risk)
Clinical Study IdentifierNCT03661034
SponsorCognito Therapeutics, Inc.
Last Modified on22 January 2021

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