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Sensory-Evoked Cortical Gamma Oscillation for Alzheimer's Disease

This study is testing a device called Cognito Therapeutics GammaSense Stimulation, which uses gentle light and sound (sensory stimulation) at a specific rate (40 Hz) for one hour daily. Researchers want to see if this stimulation can improve brain function and thinking skills in people with Alzheimer's disease. They will measure changes in brain activity (Cortical Network Functioning) and memory/thinking abilities (Cognitive Status) after 8 weeks. To join, you must be 60 or older with an Alzheimer's diagnosis, speak English, and be able to give your own consent. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will use the GammaSense Stimulation device for one hour each day for 8 weeks. Brain activity and cognitive tests will be done before and after this 8-week period.
Compensation
Not stated in the trial record.
Follow-up
If significant changes are seen after 8 weeks of therapy, neurophysiological testing will be repeated 4 weeks after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05206305

Sensory-Evoked Cortical Gamma Oscillation

Active, Not Recruiting
NAAges 60+InterventionalTreatment
University of Tennessee Medical Center
~20 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:GammaSense Stimulation device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cortical Network Functioning
Measured over 8 weeks
+1 more outcome measured

Conditions

Alzheimer Disease

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Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Roberto Fernandez-Romero, MD · PRINCIPAL_INVESTIGATOR · University of Tennessee Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals ages 60 and older with established diagnosis of Alzheimer's Disease as defined by the current consensus criteria for AD (Albert et al, 2011, Jack et al, 2011; McKhann et al, 2011)
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

Not fluent and literate in English
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

What this trial measures

  • Cortical Network Functioning8 weeks

    Cortical visual processing assessed before and after first therapy session to evaluate immediate impact of therapy device on cortical network functioning. The same measurements will be applied again at the conclusion of 8 week therapy period to evaluate impact of the therapy device on cortical network functioning over the total study period.

  • Cognitive Status8 weeks

    Neuropsychological tests administered before \& after 8 week therapy period. Aggregate scoring: Range 1-4. 1=All scores better than normal. 2=All scores normal. 3=1-2 scores abnormal 4=3+ scores abnormal. Tests administered are: * Montreal Cognitive Assessment (MoCA) tests memory, attention, language. Score range 0-30. * Craft Story 21 Recall (Immediate and Delayed) tests memory. Score range 0-44. * Benson Complex Figure (Copy and Recall) tests memory, visuospatial perceptive, fine-motor coordination. Score range 0-17. * Number Span (Forward and Backward) tests memory. Score range 0-14. * Category Fluency (Animals and Vegetables) tests verbal fluency, semantic memory. Score range 0-77. * Trail Making (A and B) tests visuomotor and perceptual scanning abilities. Score range 0-150 A (numerical sequence) \& 0-300 B (letter sequence). * Multilingual Naming test (MINT) tests naming impairment. Score range 0-32.