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



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:12/19/2018
Start Date:May 31, 2018
End Date:November 1, 2019
Contact:Evan R Hempel
Email:info@cognitotx.com
Phone:857-201-5088

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

Inclusion Criteria:

- >= 50 Years Old

- MMSE 24 - 30

- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD

- Participation of a caregiver / care partner

- Amyloid Positive PET Scan

Exclusion Criteria:

- Profound hearing or visual impairment

- Seizure Disorder

- Use of memantine (Namenda or Namzaric)

- Implantable devices (non-MR compatible)
We found this trial at
1
site
Boston Center for Memory
Newton, Massachusetts 02459
Phone: 617-699-6927
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mi
from
Newton, MA
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