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NCT03661034

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

Status unknown NA Last updated 24 August 2021
What this trial tests

NA trial testing GammaSense Stimulation System (non-invasive, non-significant risk) in Alzheimer Disease, Early Onset in 20 participants. Status unknown.

Timeline
31 May 2018
Primary endpoint
1 May 2021
1 March 2022

Quick facts

Lead sponsorCognito Therapeutics, Inc.
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment20
Start date31 May 2018
Primary completion1 May 2021
Estimated completion1 March 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cognito Therapeutics, Inc.

Who can join

50 and older, any sex, with Alzheimer Disease, Early Onset or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Modulation of Brain Hyperexcitability: Potential New Therapeutic Approaches in Alzheimer's Disease.
    Toniolo S, Sen A, Husain M. · · 2020 · cited 74× · PMID 33297460 · DOI 10.3390/ijms21239318
  2. Therapy for Alzheimer's disease: Missing targets and functional markers?
    Stoiljkovic M, Horvath TL, Hajós M. · · 2021 · cited 52× · PMID 33711510 · DOI 10.1016/j.arr.2021.101318
  3. Abstract: Posters: 13th Clinical Trials on Alzheimer's Disease (CTAD) November 4-7, 2020.
    · 2020 · cited 2× · PMID 33169785 · DOI 10.14283/jpad.2020.58

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