Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease

Study Overview
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Brief Summary
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In this study, it is aimed to compare the effects of cognitive exercises applied on long-term internet environment to the cognitive level of patients who received donepezil, memantine or donepezil / memantin combination therapy.

Official Title
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Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease Receiving Donepezil, Memantine or Donepezil/Memantine Combination Therapy: Open-Labeled, Randomized, Phase IV, Superiority Study

Conditions
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Alzheimer Disease, Cognitive Change

Intervention / Treatment
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* Combination Product: Ebicomb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 55-90 years old who were diagnosed with Alzheimer's Dementia and had no history of cerebrovascular disease during the last 6 months, Patients without other neurodegenerative diseases and secondary dementia diagnoses, Patients with MOCA score of between 13-18, Patients with at least primary school graduation, Patients who have had no CNS disease including trauma in the last year, Patients without a diagnosis of psychiatric disease, Patients with a tablet or PC with an internet connection, Patients agreeing to perform BEYNEX daily activity at least 5 times per week, Patients signing informed consent form. Exclusion Criteria: Patients who have hypersensitivity to study working drugs, Psychotic patients, Disabled patients with orthopedic dominant extremity, Patients with ICU follow-up due to trauma in the last 6 months, Patients with severe visual impairment or eye surgery, Patients who refuse to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Donepezil/Memantin Combination | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|
| Experimental: Group B<br>Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software) | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|
| Active Comparator: Group C<br>Donepezil Mono | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|
| Active Comparator: Group D<br>Donepezil Mono + Cognitive Exercises (BEYNEX Software) | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|
| Active Comparator: Group E<br>Memantine Mono | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|
| Active Comparator: Group F<br>Memantine Mono + Cognitive Exercises (BEYNEX Software) | Combination Product: Ebicomb<br>* Combination product and combination product plus cognitive exercises will primarily be evaluated in this study<br>* Other names: Donepezil-Memantine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MOCA total score | MOCA: Montreal - Cognitive Assessment | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GDS total score | GDS (The Geriatric Depression Scale) | 6-months | 
| Change in ADAS-Cog total score | ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale | 6-months | 
| Change in CDR total score | CDR: The Clinical Dementia Rating | 6-months | 
| Change in B-ADL total score | B-ADL: The Bayer Activities of Daily Living Scale | 6-months | 
| Change in clock drawing test | The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm) and will be evaluated according to ability to draw. | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination