NCT05206305

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
26mo left

Started Jul 2022

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jul 2022Jun 2028

First Submitted

Initial submission to the registry

December 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

December 17, 2021

Last Update Submit

April 27, 2026

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (1)

  • Resting state functional magnetic resonance imaging

    8 weeks

Study Arms (1)

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.

Device: GammaSense Stimulation device

Interventions

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.

AD Patients

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Roberto Fernandez-Romero, MD

    University of Tennessee Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 25, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)