UnknownNot Applicable

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

United States20 participantsStarted 2018-05-31

Plain-language 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.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in Amyloid Positron Emission Tomography (PET) Scan

Timeframe: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)

Adverse Events

Timeframe: Over 12 months

Trial details

NCT IDNCT03661034

SponsorCognito Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-01

View on ClinicalTrials.gov More Alzheimer Disease, Early Onset trials