Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
1 other identifier
interventional
198
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 alzheimer-disease
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 17, 2022
May 1, 2022
2.4 years
April 9, 2019
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in MOCA total score
MOCA: Montreal - Cognitive Assessment
6-months
Secondary Outcomes (5)
Change in GDS total score
6-months
Change in ADAS-Cog total score
6-months
Change in CDR total score
6-months
Change in B-ADL total score
6-months
Change in clock drawing test
6-months
Study Arms (6)
Group A
EXPERIMENTALDonepezil/Memantin Combination
Group B
EXPERIMENTALDonepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
Group C
ACTIVE COMPARATORDonepezil Mono
Group D
ACTIVE COMPARATORDonepezil Mono + Cognitive Exercises (BEYNEX Software)
Group E
ACTIVE COMPARATORMemantine Mono
Group F
ACTIVE COMPARATORMemantine Mono + Cognitive Exercises (BEYNEX Software)
Interventions
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maltepe University Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Türker Şahiner, Prof Dr
Project Consultant
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
May 17, 2019
Study Start
October 15, 2020
Primary Completion
March 1, 2023
Study Completion
March 1, 2024
Last Updated
May 17, 2022
Record last verified: 2022-05