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出境医 / 临床实验 / Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease

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

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Change Combination Product: Ebicomb Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Group A
Donepezil/Memantin Combination
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Experimental: Group B
Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Active Comparator: Group C
Donepezil Mono
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Active Comparator: Group D
Donepezil Mono + Cognitive Exercises (BEYNEX Software)
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Active Comparator: Group E
Memantine Mono
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Active Comparator: Group F
Memantine Mono + Cognitive Exercises (BEYNEX Software)
 Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Outcome Measures
Primary Outcome Measures :
  1. Change in MOCA total score [ Time Frame: 6-months ]
    MOCA: Montreal - Cognitive Assessment


Secondary Outcome Measures :
  1. Change in GDS total score [ Time Frame: 6-months ]
    GDS (The Geriatric Depression Scale)

  2. Change in ADAS-Cog total score [ Time Frame: 6-months ]
    ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale

  3. Change in CDR total score [ Time Frame: 6-months ]
    CDR: The Clinical Dementia Rating

  4. Change in B-ADL total score [ Time Frame: 6-months ]
    B-ADL: The Bayer Activities of Daily Living Scale

  5. Change in clock drawing test [ Time Frame: 6-months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Neutec RD 00 90 (505) 174379 02 ext 0000 iremkaraman@neutecrdc.com

Locations
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Turkey
Maltepe University Hospital Recruiting
Istanbul, Turkey
Contact: Nilgün Çınar         
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş
Investigators
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Study Chair: Türker Şahiner, Prof Dr Project Consultant
Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE October 15, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		Change in MOCA total score [ Time Frame: 6-months ]
MOCA: Montreal - Cognitive Assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Change in GDS total score [ Time Frame: 6-months ]
    GDS (The Geriatric Depression Scale)
  • Change in ADAS-Cog total score [ Time Frame: 6-months ]
    ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
  • Change in CDR total score [ Time Frame: 6-months ]
    CDR: The Clinical Dementia Rating
  • Change in B-ADL total score [ Time Frame: 6-months ]
    B-ADL: The Bayer Activities of Daily Living Scale
  • Change in clock drawing test [ Time Frame: 6-months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Cognitive Change
Intervention  ICMJE Combination Product: Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
Other Name: Donepezil-Memantine
Study Arms  ICMJE
  • Experimental: Group A
    Donepezil/Memantin Combination
    Intervention: Combination Product: Ebicomb
  • Experimental: Group B
    Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
    Intervention: Combination Product: Ebicomb
  • Active Comparator: Group C
    Donepezil Mono
    Intervention: Combination Product: Ebicomb
  • Active Comparator: Group D
    Donepezil Mono + Cognitive Exercises (BEYNEX Software)
    Intervention: Combination Product: Ebicomb
  • Active Comparator: Group E
    Memantine Mono
    Intervention: Combination Product: Ebicomb
  • Active Comparator: Group F
    Memantine Mono + Cognitive Exercises (BEYNEX Software)
    Intervention: Combination Product: Ebicomb
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		198
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neutec RD 00 90 (505) 174379 02 ext 0000 iremkaraman@neutecrdc.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954613
Other Study ID Numbers  ICMJE NEU-05.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neutec Ar-Ge San ve Tic A.Ş
Study Sponsor  ICMJE Neutec Ar-Ge San ve Tic A.Ş
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Türker Şahiner, Prof Dr Project Consultant
PRS Account Neutec Ar-Ge San ve Tic A.Ş
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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