Istanbul Medipol University
Istanbul, Beykoz, 34810, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06595511
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.
Interested in participating?
Request Info60 year–86 year
All sexes
Interventional
Not applicable
Istanbul, Beykoz, 34810, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion and Exclusion Criteria for Alzheimer Patients:
Inclusion criteria
Exclusion criteria
Inclusion and Exclusion Criteria of Healthy Older Adults:
Inclusion criteria
Exclusion criteria
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.
Time frame: At baseline and month 3
EEG will be recorded under these conditions:
Time frame: At baseline and month 3
For the comprehensive cognitive status
Time frame: At baseline and month 3
For the assessment of memory functions
Time frame: At baseline and month 3
For the assessment of attention
Time frame: At baseline and month 3
For the assessments of executive function
Time frame: At baseline and month 3
For the assessment of language functions
Time frame: At baseline and month 3
For the assessment of visuospatial functions
Time frame: month 1 and 2
EEG will be recorded under these conditions:
Contact information is provided by the study sponsor or research team.
Istanbul Medipol University Hospital
Other
Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07214727
Alzheimer Disease, Alzheimer's Disease
Montreal, Canada
View Trial DetailsNCT00869817
Alzheimer Disease, Alzheimer disease type 4
Jacksonville, Florida, United States
View Trial DetailsNCT05462106
Abnormalities, Multiple, Alzheimer Disease
Phoenix, Arizona, United States
View Trial DetailsNCT04396873
ALS, Alzheimer Disease
Bethesda, Maryland, United States
View Trial Details