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Sensory Stimulation to Improve Brain Function (Overture Study)

Active, not recruiting

The Overture Study is a Phase I/II clinical trial to study safety, adherence rates, and efficacy of the Active GammaSense Stimulation System in older adults with mild cognitive impairment (MCI) and Alzheimer's disease. The device provides noninvasive auditory and visual sensory stimulation to the brain.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A All No
April 24, 2018
August 2021
60

  • Mini-Mental State Examination Score of 14 to 26
  • Early Alzheimers disease, Alzheimers disease, or MCI due to Alzheimers disease
  • Participation of a caregiver

  • Profound hearing or visual impairment
  • Seizure disorder
  • Use of memantine (Namenda or Namzaric)
  • Implantable devices that are not compatible with magnetic resonance imaging

Participants will be randomly assigned to the Active GammaSense Stimulation System or sham device for 60 minutes daily for 6 months. The stimulation device provides noninvasive auditory and visual sensory stimulation to the brain. At intervals during the trial, participants will be evaluated for cognitive function using a 14-question assessment and will undergo a positron emission tomography/computed tomography scan.

Name City State Zip Status Primary Contact
Brain Matters Research
Delray Beach Florida 33445

Brain Matters Research
Stuart Florida 34994

ActivMed Practices & Research, Inc
Methuen Massachusetts 01844

Boston Center for Memory
Newton Massachusetts 02459

ActivMed Practices & Research, Inc
Portsmouth New Hampshire 02801

The Cognitive and Research Center of New Jersey
Springfield New Jersey 07081

Cognito Therapeutics, Inc.

Name Phone Email
Evan R. Hempel 857-201-5088 info@cognitotx.com

NCT03556280

Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)