Multi-Center Study of Sensory Stimulation to Improve Brain Function
NCT ID: NCT03556280
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2018-04-24
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Group
Will use the Active GammaSense Stimulation System.
GammaSense Stimulation System (Active Settings)
Proprietary auditory and visual sensory stimulation device.
Control Group
Will use the Sham GammaSense Stimulation System.
GammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.
Interventions
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GammaSense Stimulation System (Active Settings)
Proprietary auditory and visual sensory stimulation device.
GammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.
Eligibility Criteria
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Inclusion Criteria
* MMSE 14-26
* Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
* Participation of a caregiver
Exclusion Criteria
* Seizure Disorder
* Use of memantine (Namenda or Namzaric)
* Implantable devices (non-MR compatible)
55 Years
ALL
No
Sponsors
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Cognito Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Brain Matters Research
Delray Beach, Florida, United States
Brain Matters Research
Stuart, Florida, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Countries
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References
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Carbonell F, Zijdenbos AP, Hempel E, Hajos M, Bedell BJ. A novel method for harmonization of PET image spatial resolution without phantoms. EJNMMI Phys. 2025 Mar 14;12(1):23. doi: 10.1186/s40658-025-00740-9.
Hajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024.
Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
Other Identifiers
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CA-0005
Identifier Type: -
Identifier Source: org_study_id
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