Vascular DementiaPhase 3MINDNCT03986424
Local Study of Akatinol Memantine in VaD in Russia
A Phase 3 study testing Akatinol Memantine 20 mg and Akatinol Memantine 10 mg in people with Vascular Dementia, run by Merz Pharmaceuticals GmbH at 4 sites in Russia.
Trial summary
The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- Akatinol Memantine 20 mg and Akatinol Memantine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesRussia
- Study dates
- 23 Jan 2018to 1 Jun 2022
- Phase
- Phase 3
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.
- Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.
- Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.
- Mini-Mental State Examination (MMSE) Test total scores of 10 to 20.
- Hachinski's Ischemic Score (HIS) of 7 or higher point.
- Availability in the anamnesis of instrumental confirmation of the diagnosis (data methods of neurovisualization - CT or MRT).
- For females: menopause or inability to conceive due to other reasons (hysterectomy, etc.).
- Availability of a relative or legal representative who lives with the patient, monitors him/her and cares for the patient.
Who cannot join
- Alzheimer's disease or secondary types of dementia.
- Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).
- Other clinically significant neurological or psychiatric disorders.
- Severe depression (Hamilton score, HAM-D > 18 points).
- Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.
- Contraindications to oral drug intake during the time period determined by the study protocol.
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- Known hypersensitivity to the investigational product or any of its ingredients.
- Administration of nootropic, anti-dementia and typical antipsychotic drugs, tricyclic antidepressants, long-acting benzodiazepines, NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) for 1 month before the enrollment and during the study.
- For females: pregnancy and breastfeeding.
- Evidence or suspicion that the patient might not comply with the study directive.
- Any reason or contraindication which in the investigator's opinion precludes participation in the study.
- Patient is direct relative of an employee of the study site or Merz Pharma LLC.
- Previous participation in this clinical study.
- Participation in another clinical trial within the last 12 weeks prior to screening or ongoing participation in a study.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Federal State Budgetary Scientific Institution "Mental Health Research Center"
Moscow, 115522
Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
Moscow, 117198
Scientific Research Institute of Neurology, Merz Investigational Site #0070008
Moscow, 125367
Federal state budgetary military educational institution of higher education "Military Medical Academy named after S.M. Kirov" of the Ministry of defence of the Russian Federation
Saint Petersburg, 194044
About this study
Official title: Multi-center Open Comparative Randomized Study of Efficacy and Safety of Akatinol Memantine 20 mg (Single-doses) vs. Akatinol Memantine 10 mg (Double-doses) in Patients With Moderate and Moderately Severe Vascular Dementia
The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia.
- Conditions
- Vascular Dementia
- Being tested
- Akatinol Memantine 20 mg, Akatinol Memantine 10 mg
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akatinol Memantine 20 mgDrug
Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
Akatinol Memantine 10 mgDrug
Akatinol Memantine 10 mg to be taken orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Akatinol Memantine 20 mg | Experimental | Akatinol Memantine 20 mg once daily Receives: Drug: Akatinol Memantine 20 mg |
| Akatinol Memantine 10 mg | Active comparator | Akatinol Memantine 10 mg twice daily Receives: Drug: Akatinol Memantine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total ADAS-cog score points
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start23 Jan 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Responsible party
- Sponsor
- Investigators
- Merz Russia Medical Expert, Study director, Merz Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986424
- Sponsor's protocol ID
- M900011005
- Acronym
- MIND
- Status last verified
- Jul 2022
- First submitted
- 11 Jun 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Open Comparative Randomized Study of Efficacy and Safety of Akatinol Memantine 20 mg (Single-doses) vs. Akatinol Memantine 10 mg (Double-doses) in Patients With Moderate and Moderately Severe Vascular Dementia
- ClinicalTrials.gov ID
- NCT03986424
- Acronym / sponsor ID
- MIND / M900011005
- Conditions
- Vascular Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 14 Jun 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.
The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Akatinol Memantine 20 mg | Experimental | Drug: Akatinol Memantine 20 mgAkatinol Memantine 20 mg once daily |
| Akatinol Memantine 10 mg | Active comparator | Drug: Akatinol Memantine 10 mgAkatinol Memantine 10 mg twice daily |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.
- Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.
- Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.
- Mini-Mental State Examination (MMSE) Test total scores of 10 to 20.
- Hachinski's Ischemic Score (HIS) of 7 or higher point.
Key exclusion criteria (14 listed)
- Alzheimer's disease or secondary types of dementia.
- Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).
- Other clinically significant neurological or psychiatric disorders.
- Severe depression (Hamilton score, HAM-D > 18 points).
- Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.
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 |
|---|---|---|
| Akatinol Memantine 20 mgAkatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day | Drug | Akatinol Memantine 20 mg |
| Akatinol Memantine 10 mgAkatinol Memantine 10 mg to be taken orally, twice daily | Drug | Akatinol Memantine 10 mg |
Primary outcome
Change from baseline in total ADAS-cog score points
Time frame: 24 weeks
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Merz Russia Medical Expert study director
Merz Russia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Akatinol Memantine 20 mg and Akatinol Memantine 10 mg in people with Vascular Dementia, run by Merz Pharmaceuticals GmbH at 4 sites in Russia.
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total ADAS-cog score points (time frame: 24 weeks). 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 22 Jul 2022.