Alzheimer DiseasePhase 4NCT03954613
Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
A Phase 4 study testing Ebicomb in people with Alzheimer Disease and Cognitive Change, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease, Cognitive Change
- What is being tested?
- Ebicomb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Maltepe University Hospital
Istanbul
Nilgün Çınar
About this study
Official title: 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
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.
- Conditions
- Alzheimer Disease, Cognitive Change
- Being tested
- Ebicomb
- Keywords
- Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbicombCombination product
Also called Donepezil-Memantine
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Donepezil/Memantin Combination Receives: Combination Product: Ebicomb |
| Group B | Experimental | Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software) Receives: Combination Product: Ebicomb |
| Group C | Active comparator | Donepezil Mono Receives: Combination Product: Ebicomb |
| Group D | Active comparator | Donepezil Mono + Cognitive Exercises (BEYNEX Software) Receives: Combination Product: Ebicomb |
| Group E | Active comparator | Memantine Mono Receives: Combination Product: Ebicomb |
| Group F | Active comparator | Memantine Mono + Cognitive Exercises (BEYNEX Software) Receives: Combination Product: Ebicomb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MOCA total score
MOCA: Montreal - Cognitive Assessment
Measured: 6-months
Secondary outcomes (5)
Change in GDS total score
GDS (The Geriatric Depression Scale)
Measured: 6-months
Change in ADAS-Cog total score
ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
Measured: 6-months
Change in CDR total score
CDR: The Clinical Dementia Rating
Measured: 6-months
Change in B-ADL total score
B-ADL: The Bayer Activities of Daily Living Scale
Measured: 6-months
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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start15 Oct 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Türker Şahiner, Prof Dr, Study chair, Project Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954613
- Sponsor's protocol ID
- NEU-05.18
- Status last verified
- May 2022
- First submitted
- 9 Apr 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03954613
- Acronym / sponsor ID
- NEU-05.18
- Conditions
- Alzheimer Disease, Cognitive Change
- Keywords
- Alzheimer Disease, Cognitive Exercises, Internet, Donepezil, Memantin, Combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: EbicombDonepezil/Memantin Combination |
| Group B | Experimental | Combination Product: EbicombDonepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software) |
| Group C | Active comparator | Combination Product: EbicombDonepezil Mono |
| Group D | Active comparator | Combination Product: EbicombDonepezil Mono + Cognitive Exercises (BEYNEX Software) |
| Group E | Active comparator | Combination Product: EbicombMemantine Mono |
| Group F | Active comparator | Combination Product: EbicombMemantine Mono + Cognitive Exercises (BEYNEX Software) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EbicombAlso: Donepezil-MemantineCombination product and combination product plus cognitive exercises will primarily be evaluated in this study | Combination product | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
Change in MOCA total score
Time frame: 6-months
MOCA: Montreal - Cognitive Assessment
5 secondary outcomes
Change in GDS total score
Time frame: 6-months
Change in ADAS-Cog total score
Time frame: 6-months
Change in CDR total score
Time frame: 6-months
Change in B-ADL total score
Time frame: 6-months
Change in clock drawing test
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Türker Şahiner, Prof Dr study chair
Project Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ebicomb in people with Alzheimer Disease and Cognitive Change, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neutec RD (00908502012323 ext. 0000, iremkaraman@neutecrdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MOCA total score (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.