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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
| Guven Health Group | OTHER |
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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.
This study aims to recruit early and middle-stage Alzheimer patients aged between 60 and 75, along with age and gender-matched healthy older adults. Two different Alzheimer groups will be created: one group will utilize a 40 Hz sensory entrainment-integrated cognitive game kit at home, while the other group will not receive any treatment. The treatment group will comprise 10 Alzheimer patients who will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for 1 hour a day, at least five days a week, for three months. Comprehensive neuropsychological assessments and electroencephalography (EEG) recordings will be conducted in the laboratory on the first day, followed by mobile EEG recordings at home at the end of the first and second months. After three months of using the sensory entrainment/cognitive game kit, the participants will again undergo neuropsychological assessment and EEG recording in the laboratory. The second Alzheimer group (n=10) will not be administered any treatment and will undergo the same assessment protocol as the treatment group. Furthermore, in addition to these two groups, a healthy older adult group (n=10) will also be included in the study, with assessments scheduled only on the first day and at the end of the third month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease Treatment Group | Active Comparator | The group will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for one hour a day, five days a week, for three months. |
|
| Alzheimer's Disease Control Group | No Intervention | ||
| Healthy Older Adult Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory Entrainment-Integrated Cognitive Game Kit | Device | Active comparator group will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for one hour a day, at least five days a week, for three months. |
| Measure | Description | Time Frame |
|---|---|---|
| EEG recording | EEG will be recorded under these conditions:
| At baseline and month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Mini Mental State Examination (SMMSE) | For the comprehensive cognitive status | At baseline and month 3 |
| Verbal memory processes test (Öktem-SBST) and Wechsler Visual Production Subtest |
| Measure | Description | Time Frame |
|---|---|---|
| Mobile EEG recording at home | EEG will be recorded under these conditions:
| month 1 and 2 |
Inclusion and Exclusion Criteria for Alzheimer Patients:
Inclusion Criteria:
Exclusion Criteria:
Inclusion and Exclusion Criteria of Healthy Older Adults:
Inclusion criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bahar Güntekin, PhD | Contact | +90 5326031560 | bguntekin@medipol.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Recruiting | Istanbul | Beykoz | 34810 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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For the assessment of memory functions
| At baseline and month 3 |
| WMS-R Digit Span Test | For the assessment of attention | At baseline and month 3 |
| Stroop Test, Clock Drawing Test, Verbal Fluency Tests (categorical and phonemic) and Trail Making Test | For the assessments of executive function | At baseline and month 3 |
| Boston Naming Test | For the assessment of language functions | At baseline and month 3 |
| Benton Line Orientation Test and Benton Face Recognition Test | For the assessment of visuospatial functions | At baseline and month 3 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |