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

    Not Recruiting
  • participants needed
  • 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
sensory stimulation


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.


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.

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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