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.
Investigators
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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