Alzheimer's DiseaseNCT06595511
Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease
A study testing Sensory Entrainment-Integrated Cognitive Game Kit in people with Alzheimer's Disease and 40 Hz Stimulation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, 40 Hz Stimulation, EEG Brain Oscillations
- What is being tested?
- Sensory Entrainment-Integrated Cognitive Game Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Between the ages of 60-86
Show all 9Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Beykoz, 34810
Bahar Güntekin, PhD, +90 5326031560, bguntekin@medipol.edu.tr
About this study
Official title: Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease
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.
Read the detailed description
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.
- Being tested
- Sensory Entrainment-Integrated Cognitive Game Kit
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Entrainment-Integrated Cognitive Game KitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sensory Entrainment-Integrated Cognitive Game Kit |
| Alzheimer's Disease Control Group | No intervention | Not described |
| Healthy Older Adult Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG recording
EEG will be recorded under these conditions:
- Spontaneous EEG (8 minutes eyes open, 8 minutes eyes closed)
- Visual oddball
- Auditory oddball
- 40 Hz flicker stimulation EEG recording (8 minutes eyes open, 8 minutes eyes closed)
Measured: At baseline and month 3
Secondary outcomes (6)
Standardized Mini Mental State Examination (SMMSE)
For the comprehensive cognitive status
Measured: At baseline and month 3
Verbal memory processes test (Öktem-SBST) and Wechsler Visual Production Subtest
For the assessment of memory functions
Measured: At baseline and month 3
WMS-R Digit Span Test
For the assessment of attention
Measured: 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
Measured: At baseline and month 3
Boston Naming Test
For the assessment of language functions
Measured: At baseline and month 3
Benton Line Orientation Test and Benton Face Recognition Test
For the assessment of visuospatial functions
Measured: At baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Guven Health Group
- Responsible party
- Principal investigator, Bahar Güntekin, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595511
- Sponsor's protocol ID
- E-10840098-772.02-6692
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06595511
- Acronym / sponsor ID
- E-10840098-772.02-6692
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Guven Health Group
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease Treatment Group | Active comparator | Device: Sensory Entrainment-Integrated Cognitive Game KitThe 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 | – |
Who may qualify
- Ages
- 60 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
- 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
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 |
|---|---|---|
| Sensory Entrainment-Integrated Cognitive Game KitActive 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. | Device | Alzheimer's Disease Treatment Group |
Primary outcome
EEG recording
Time frame: At baseline and month 3
EEG will be recorded under these conditions: * Spontaneous EEG (8 minutes eyes open, 8 minutes eyes closed) * Visual oddball * Auditory oddball * 40 Hz flicker stimulation EEG recording (8 minutes eyes open, 8 minutes eyes closed)
6 secondary outcomes
Standardized Mini Mental State Examination (SMMSE)
Time frame: At baseline and month 3
Verbal memory processes test (Öktem-SBST) and Wechsler Visual Production Subtest
Time frame: At baseline and month 3
WMS-R Digit Span Test
Time frame: At baseline and month 3
Stroop Test, Clock Drawing Test, Verbal Fluency Tests (categorical and phonemic) and Trail Making Test
Time frame: At baseline and month 3
Boston Naming Test
Time frame: At baseline and month 3
Benton Line Orientation Test and Benton Face Recognition Test
Time frame: At baseline and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Entrainment-Integrated Cognitive Game Kit in people with Alzheimer's Disease and 40 Hz Stimulation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar Güntekin, PhD (+90 5326031560, bguntekin@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG recording (time frame: At baseline and month 3). 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 19 Sep 2024.