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Clinical Trials/NCT03954613
NCT03954613
Unknown
Phase 4

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

Neutec Ar-Ge San ve Tic A.Ş1 site in 1 country198 target enrollmentOctober 15, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
Enrollment
198
Locations
1
Primary Endpoint
Change in MOCA total score
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
March 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in MOCA total score

Time Frame: 6-months

MOCA: Montreal - Cognitive Assessment

Secondary Outcomes

  • 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 Sites (1)

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