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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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-07-01
2026-06-30
Brief Summary
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Detailed Description
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The hypotheses will be tested by the following:
1. \- Elucidate the immediate impact of gamma oscillations on sensory processing and cognitive function by assessing cognitive function and cortical network function prior to the introduction of sensory stimulation and comparing it to post-therapeutic assessments immediately following the acute administration of therapy on visual processing.
2. \- Explore the short and long-term therapeutic benefits of a sub-chronic (8 weeks) treatment by assessing cognitive function and cortical network connectivity immediately after the 8 week sensory stimulation therapy. If significant changes are observed between pre-therapy and post-therapy neurophysiologic data for an individual subject, neurophysiological testing will be repeated 4 weeks following the conclusion of therapy.
3. \- Investigate the correlation between neurophysiology and cognitive function by assessing cognitive function and neurophysiological measures of cortical network activity at multiple time points to determine if therapeutic changes in one domain reflect changes related to the other domain.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AD Patients
Patients with Alzheimer's Disease, as verified by positive A(beta)-PET and/or CSF tau/A(beta) biomarkers, who will receive one hour daily gamma frequency sensory stimulation from the investigational device for an 8 week period.
GammaSense Stimulation device
Cognito Therapeutics GammaSense Stimulation device delivers sensory (auditory and visual) stimuli at a rate of 40 Hz to the wearer for one hour each day.
Interventions
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GammaSense Stimulation device
Cognito Therapeutics GammaSense Stimulation device delivers sensory (auditory and visual) stimuli at a rate of 40 Hz to the wearer for one hour each day.
Eligibility Criteria
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Inclusion Criteria
* Fluent and literate in English language
* Able to consent for themselves based upon the MacArthur Competence Assessment Tool for Clinical Research
* Patients with a pre-existing positive A(beta)-PET and/or CSF tau/A(beta) markers or willingness to undergo a Lumbar Puncture (LP) with these results
Exclusion Criteria
* Severe dementia
* Other medical conditions/neurodegenerative disease that could significantly impair cognitive abilities
* Cardiac pacemakers or any other implants that may not be compatible with MRI
* Cognitively impaired to the point the patient is unable to consent for themselves
* Claustrophobic to the point that medication is required
60 Years
ALL
No
Sponsors
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University of Tennessee Medical Center
OTHER
Responsible Party
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Principal Investigators
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Roberto Fernandez-Romero, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee Medical Center
Locations
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University of Tennessee Medical Center
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Janet H Parkey
Role: primary
David Grant
Role: backup
Other Identifiers
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ALD-001-122021
Identifier Type: -
Identifier Source: org_study_id