Back to resultsEvaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Cognitive Change
Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ebicomb
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination
Eligibility Criteria
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.
Sites / Locations
- Maltepe University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Group E
Group F
Arm Description
Donepezil/Memantin Combination
Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
Donepezil Mono
Donepezil Mono + Cognitive Exercises (BEYNEX Software)
Memantine Mono
Memantine Mono + Cognitive Exercises (BEYNEX Software)
Outcomes
Primary Outcome Measures
Change in MOCA total score
MOCA: Montreal - Cognitive Assessment
Secondary Outcome Measures
Change in GDS total score
GDS (The Geriatric Depression Scale)
Change in ADAS-Cog total score
ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
Change in CDR total score
CDR: The Clinical Dementia Rating
Change in B-ADL total score
B-ADL: The Bayer Activities of Daily Living Scale
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.
Full Information
NCT ID
NCT03954613
First Posted
April 9, 2019
Last Updated
May 16, 2022
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
1. Study Identification
Unique Protocol Identification Number
NCT03954613
Brief Title
Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Change
Keywords
Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Donepezil/Memantin Combination
Arm Title
Group B
Arm Type
Experimental
Arm Description
Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Donepezil Mono
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Donepezil Mono + Cognitive Exercises (BEYNEX Software)
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Memantine Mono
Arm Title
Group F
Arm Type
Active Comparator
Arm Description
Memantine Mono + Cognitive Exercises (BEYNEX Software)
Intervention Type
Combination Product
Intervention Name(s)
Ebicomb
Other Intervention Name(s)
Donepezil-Memantine
Intervention Description
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Primary Outcome Measure Information:
Title
Change in MOCA total score
Description
MOCA: Montreal - Cognitive Assessment
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Change in GDS total score
Description
GDS (The Geriatric Depression Scale)
Time Frame
6-months
Title
Change in ADAS-Cog total score
Description
ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
Time Frame
6-months
Title
Change in CDR total score
Description
CDR: The Clinical Dementia Rating
Time Frame
6-months
Title
Change in B-ADL total score
Description
B-ADL: The Bayer Activities of Daily Living Scale
Time Frame
6-months
Title
Change in clock drawing test
Description
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.
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neutec RD
Phone
00908502012323
Ext
0000
Email
iremkaraman@neutecrdc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Türker Şahiner, Prof Dr
Organizational Affiliation
Project Consultant
Official's Role
Study Chair
Facility Information:
Facility Name
Maltepe University Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilgün Çınar
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
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