Multi-Center Study of Sensory Stimulation to Improve Brain Function

Last updated: August 23, 2021
Sponsor: Cognito Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Memory Problems

Learning Disorders

Treatment

N/A

Clinical Study ID

NCT03556280
CA-0005
  • Ages > 55
  • All Genders

Study Summary

The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >= 55 Years old
  • MMSE 14-26
  • Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
  • Participation of a caregiver

Exclusion

Exclusion Criteria:

  • Profound hearing or visual impairment
  • Seizure Disorder
  • Use of memantine (Namenda or Namzaric)
  • Implantable devices (non-MR compatible)

Study Design

Total Participants: 60
Study Start date:
April 24, 2018
Estimated Completion Date:
September 30, 2021

Study Description

The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.

Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Connect with a study center

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Brain Matters Research

    Stuart, Florida 34994
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Boston Center for Memory

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc

    Portsmouth, New Hampshire 02801
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

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