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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 Receiving Donepezil, Memantine or Donepezil/Memantine Combination Therapy: Open-Labeled, Randomized, Phase IV, Superiority Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03954613
Enrollment
198
Registered
2019-05-17
Start date
2020-10-15
Completion date
2024-03-01
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Cognitive Change

Keywords

Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination

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.

Interventions

COMBINATION_PRODUCTEbicomb

Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Sponsors

Neutec Ar-Ge San ve Tic A.Ş
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in MOCA total score6-monthsMOCA: Montreal - Cognitive Assessment

Secondary

MeasureTime frameDescription
Change in clock drawing test6-monthsThe 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.
Change in GDS total score6-monthsGDS (The Geriatric Depression Scale)
Change in ADAS-Cog total score6-monthsADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
Change in CDR total score6-monthsCDR: The Clinical Dementia Rating
Change in B-ADL total score6-monthsB-ADL: The Bayer Activities of Daily Living Scale

Countries

Turkey (Türkiye)

Contacts

Primary ContactNeutec RD
iremkaraman@neutecrdc.com00908502012323

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026