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

NCT ID: NCT03954613

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2024-03-01

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.

Detailed Description

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Conditions

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Alzheimer Disease Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Donepezil/Memantin Combination

Group Type EXPERIMENTAL

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Group B

Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)

Group Type EXPERIMENTAL

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Group C

Donepezil Mono

Group Type ACTIVE_COMPARATOR

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Group D

Donepezil Mono + Cognitive Exercises (BEYNEX Software)

Group Type ACTIVE_COMPARATOR

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Group E

Memantine Mono

Group Type ACTIVE_COMPARATOR

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Group F

Memantine Mono + Cognitive Exercises (BEYNEX Software)

Group Type ACTIVE_COMPARATOR

Ebicomb

Intervention Type COMBINATION_PRODUCT

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Interventions

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Ebicomb

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Donepezil-Memantine

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Türker Şahiner, Prof Dr

Role: STUDY_CHAIR

Project Consultant

Locations

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Maltepe University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Neutec RD

Role: CONTACT

00908502012323 ext. 0000

Facility Contacts

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Nilgün Çınar

Role: primary

Other Identifiers

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NEU-05.18

Identifier Type: -

Identifier Source: org_study_id

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