About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Sensory Entrainment-Integrated Cognitive Game Kit
DeviceActive 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Standardized Mini Mental State Examination (SMMSE)
For the comprehensive cognitive status
Verbal memory processes test (Öktem-SBST) and Wechsler Visual Production Subtest
For the assessment of memory functions
WMS-R Digit Span Test
For the assessment of attention
Stroop Test, Clock Drawing Test, Verbal Fluency Tests (categorical and phonemic) and Trail Making Test
For the assessments of executive function
Other outcomes
Mobile EEG recording at home
EEG will be recorded under these conditions: * Spontaneous EEG (8 minutes eyes open, 8 minutes eyes closed) * 40 Hz flicker stimulation EEG recording (8 minutes eyes open, 8 minutes eyes closed) Delta, theta, alpha, beta, gamma power spectrum and phase locking indexes will be examined.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Medipol University Hospital
Lead sponsor
Medipol University
Sponsor institution
The Scientific and Technological Research Council of Turkey
Collaborator
Guven Health Group
Collaborator