Alzheimer DiseaseNCT05206305
Sensory-Evoked Cortical Gamma Oscillation
A study testing GammaSense Stimulation device in people with Alzheimer Disease, run by University of Tennessee Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to investigate the efficacy of cortical gamma oscillation on visual sensory processing and cognitive function in Alzheimer's Disease (AD) patients by combining a therapeutic sensory stimulation device capable of evoking 40-Hz gamma oscillation via non-invasive visual and auditory… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- GammaSense Stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
Official title: Sensory-Evoked Cortical Gamma Oscillation: Impact on Visual Processing and Cognitive Function in Patients With Alzheimer's Disease
The purpose of the study is to investigate the efficacy of cortical gamma oscillation on visual sensory processing and cognitive function in Alzheimer's Disease (AD) patients by combining a therapeutic sensory stimulation device capable of evoking 40-Hz gamma oscillation via non-invasive visual and auditory stimulation with pre-established markers of cortical network activity, i.e., electroencephalography (EEG) and event-related potentials (ERP), to evaluate the applicability of the 40-Hz multimodel sensory stimulation as a novel therapeutic approach for treatment of AD patients.
Read the detailed description
The central hypothesis of the study is that sustained 40Hz gamma oscillatory sensory stimulation therapy will improve cognitive function in patients with AD. The further hypothesis is that the improvement in cognitive function will result from improved connectivity and cortical network function as measured by EEG and ERP.
The hypotheses will be tested by the following:
- - 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.
- - 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.
- - 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
- Alzheimer Disease
- Being tested
- GammaSense Stimulation device
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaSense Stimulation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AD Patients | Experimental | 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. Receives: Device: GammaSense Stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Network Functioning
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.
Measured: 8 weeks
Cognitive Status
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.
Measured: 8 weeks
Secondary outcomes (1)
Resting state functional magnetic resonance imaging
Resting state fMRI performed before and after the 8 week therapy. Imaging will be compared to evaluate the impact of the investigational device on resting state cerebral network function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Fernandez-Romero, MD, Principal investigator, University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206305
- Sponsor's protocol ID
- ALD-001-122021
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-Evoked Cortical Gamma Oscillation: Impact on Visual Processing and Cognitive Function in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05206305
- Acronym / sponsor ID
- ALD-001-122021
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Tennessee Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the efficacy of cortical gamma oscillation on visual sensory processing and cognitive function in Alzheimer's Disease (AD) patients by combining a therapeutic sensory stimulation device capable of evoking 40-Hz gamma oscillation via non-invasive visual and auditory stimulation with pre-established markers of cortical network activity, i.e., electroencephalography (EEG) and event-related potentials (ERP), to evaluate the applicability of the 40-Hz multimodel sensory stimulation as a novel therapeutic approach for treatment of AD patients.
Detailed description
The central hypothesis of the study is that sustained 40Hz gamma oscillatory sensory stimulation therapy will improve cognitive function in patients with AD. The further hypothesis is that the improvement in cognitive function will result from improved connectivity and cortical network function as measured by EEG and ERP.
The hypotheses will be tested by the following:
- - 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.
- - 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.
- - 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD Patients | Experimental | Device: GammaSense Stimulation devicePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaSense Stimulation deviceCognito Therapeutics GammaSense Stimulation device delivers sensory (auditory and visual) stimuli at a rate of 40 Hz to the wearer for one hour each day. | Device | AD Patients |
Primary outcome
Cortical Network Functioning
Time frame: 8 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 Status
Time frame: 8 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.
1 secondary outcome
Resting state functional magnetic resonance imaging
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Fernandez-Romero, MD principal investigator
University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaSense Stimulation device in people with Alzheimer Disease, run by University of Tennessee Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical Network Functioning (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.