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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2023

Interventions

  • Combination Product: Ebicomb
    • Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Arms, Groups and Cohorts

  • Experimental: Group A
    • Donepezil/Memantin Combination
  • Experimental: Group B
    • Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
  • Active Comparator: Group C
    • Donepezil Mono
  • Active Comparator: Group D
    • Donepezil Mono + Cognitive Exercises (BEYNEX Software)
  • Active Comparator: Group E
    • Memantine Mono
  • Active Comparator: Group F
    • Memantine Mono + Cognitive Exercises (BEYNEX Software)

Clinical Trial Outcome Measures

Primary Measures

  • Change in MOCA total score
    • Time Frame: 6-months
    • MOCA: Montreal – Cognitive Assessment

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neutec Ar-Ge San ve Tic A.Ş
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Türker Şahiner, Prof Dr, Study Chair, Project Consultant
  • Overall Contact(s)
    • Neutec RD, 00908502012323, iremkaraman@neutecrdc.com

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