Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease

Recruiting · NCT06595511 · Interventional (participants receive a specific treatment) · Lead sponsor: Istanbul Medipol University Hospital

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Alzheimer's Disease

Interventions studied

Sensory Entrainment-Integrated Cognitive Game Kit

What this trial is about

In addition to ongoing drug treatments for Alzheimer Disease (AD), protective approaches that can halt the progression of the disease are of particular importance. This project aims to develop a digital application that can monitor cognitive impairment, using EEG findings proven effective at the clinical level in Alzheimer and various types of dementia, including sensory entrainment and digital cognitive games. To this end, a collaboration between Istanbul Medipol University and Güven Future Health Technologies Inc. will develop a device featuring audio-visual sensory entrainment and digital cognitive games. This device will be made available to Alzheimer patients, and the differences between patients who use the application for three months, patients who do not use the application, and healthy controls will be evaluated through neurological examinations, neuropsychological tests, and EEG recordings indicating cognitive functions by the neurologist, project coordinator, and bursars. Monthly assessments, including EEG recordings, will also continue at home, and an application will be created to evaluate changes in cognitive functions through EEG data. By the end of the project, an application that includes sensory entrainment and digital cognitive games, proven effective at the clinical level using EEG findings for Alzheimer dementia patients, will be developed. Additionally, a health kit capable of temporal monitoring of cognitive function changes through EEG data will have been developed.

Who can take part

Age range

60 Years to 86 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

Inclusion and Exclusion Criteria for Alzheimer Patients: Inclusion Criteria: * Diagnosed with AD according to DSM-IV and NINCDS-ADRDA criteria, * Impaired activities of daily living, * Having a CDR score of 1-2 and an SMMT score of 15-26, * Stable use of psychoactive medications, including acetylcholinesterase inhibitors or other medications that enhance cognitive functions, * Individuals aged 60-86 with at least 5 years of education. Exclusion Criteria: * Having frontotemporal dementia, vascular dementia, Lewy body dementia or other types of dementia, * Parkinsonism, clinical depression, other mental disorders, epilepsy, drug addiction, alcohol addiction, and traumatic brain injury Inclusion and Exclusion Criteria of Healthy Older Adults: Inclusion criteria: * Between the ages of 60-86 * Without any neurological abnormalities or general cognitive impairment (MMSE above 25), * Not diagnosed with a neurological and/or psychiatric disease, * Not using neurological and/or psychiatric medication Exclusion criteria * Having clinical signs of cognitive impairment, such as mild cognitive impairment, Alzheimer disease, Parkinson disease, Lewy body dementia, frontotemporal dementia, etc. * Epilepsy, alcohol and/or drug addiction, use of medications that affect cognitive functions, and traumatic brain injury

Where it is running

1 location listed.

Istanbul Medipol University - Istanbul, Beykoz, Turkey (Türkiye)

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →