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 range

50 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

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