ClinicalTrials.gg
Status unknownNCT03954613Updated May 17, 2022

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

A Phase 4 interventional study of Ebicomb in Alzheimer Disease and Cognitive Change, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Status unknown at 1 site in Turkey. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease
  • Cognitive Change

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Keywords

  • Alzheimer Disease
  • Cognitive Exercises
  • Internet
  • Donepezil
  • Memantin
  • Combination
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 198 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  • Patients who have 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 form.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    Group A

    Donepezil/Memantin Combination

    Combination Product: Ebicomb

  • Experimental
    Group B

    Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)

    Combination Product: Ebicomb

  • Active comparator
    Group C

    Donepezil Mono

    Combination Product: Ebicomb

  • Active comparator
    Group D

    Donepezil Mono + Cognitive Exercises (BEYNEX Software)

    Combination Product: Ebicomb

  • Active comparator
    Group E

    Memantine Mono

    Combination Product: Ebicomb

  • Active comparator
    Group F

    Memantine Mono + Cognitive Exercises (BEYNEX Software)

    Combination Product: Ebicomb

Interventions

  • Combination productEbicomb

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

    Also known as: Donepezil-Memantine

06

What researchers measure

Primary outcomes

  1. Change in MOCA total score

    MOCA: Montreal - Cognitive Assessment

    Time frame: 6-months

Secondary outcomes

  1. Change in GDS total score

    GDS (The Geriatric Depression Scale)

    Time frame: 6-months

  2. Change in ADAS-Cog total score

    ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale

    Time frame: 6-months

  3. Change in CDR total score

    CDR: The Clinical Dementia Rating

    Time frame: 6-months

  4. Change in B-ADL total score

    B-ADL: The Bayer Activities of Daily Living Scale

    Time frame: 6-months

  5. Change in clock drawing test

    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.

    Time frame: 6-months

07

Study locations

1 of 1 sites recruiting
  • Maltepe University Hospital
    Istanbul, Turkey
    Recruiting
    • Nilgün Çınar · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03954613
Lead sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Oct 15, 2020
Primary completion
Mar 1, 2023 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
May 17, 2022

Study contacts

Neutec RD
Contact
iremkaraman@neutecrdc.com
00908502012323 ext. 0000
Türker Şahiner, Prof Dr
study chair · Project Consultant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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