Alzheimer's Disease Clinical Trials

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Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 86
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Turkey
Istanbul Medipol University
RECRUITING
Istanbul
Contact Information
Primary
Bahar Güntekin, PhD
bguntekin@medipol.edu.tr
+90 5326031560
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 30
Treatments
Active_comparator: Alzheimer's Disease Treatment Group
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.
No_intervention: Alzheimer's Disease Control Group
No_intervention: Healthy Older Adult Group
Related Therapeutic Areas
Sponsors
Collaborators: Guven Health Group, The Scientific and Technological Research Council of Turkey
Leads: Istanbul Medipol University Hospital

This content was sourced from clinicaltrials.gov