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CompletedNCT03986424MINDUpdated Jul 22, 2022

Local Study of Akatinol Memantine in VaD in Russia

A Phase 3 interventional study of Akatinol Memantine 20 mg and Akatinol Memantine 10 mg in Vascular Dementia, sponsored by Merz Pharmaceuticals GmbH. Completed at 4 sites in Russian Federation. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Merz Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2018, registered Jun 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Dementia
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 130 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Merz Pharmaceuticals GmbH is the lead sponsor of 60 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Akatinol Memantine 20 mg

    Akatinol Memantine 20 mg once daily

    Drug: Akatinol Memantine 20 mg

  • Active comparator
    Akatinol Memantine 10 mg

    Akatinol Memantine 10 mg twice daily

    Drug: Akatinol Memantine 10 mg

Interventions

  • DrugAkatinol Memantine 20 mg

    Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day

  • DrugAkatinol Memantine 10 mg

    Akatinol Memantine 10 mg to be taken orally, twice daily

06

What researchers measure

Primary outcomes

  1. Change from baseline in total ADAS-cog score points

    ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale

    Time frame: 24 weeks

07

Study locations

4 sites
  • Federal State Budgetary Scientific Institution "Mental Health Research Center"
    Moscow, 115522, Russian Federation
  • Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
    Moscow, 117198, Russian Federation
  • Scientific Research Institute of Neurology, Merz Investigational Site #0070008
    Moscow, 125367, Russian Federation
  • 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
    Sankt-Peterburg, 194044, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

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 Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03986424
Lead sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia
Responsible party
Sponsor
First posted
Jun 14, 2019
Start date
Jan 23, 2018
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Jul 22, 2022

Study contacts

Merz Russia Medical Expert
study director · Merz Russia

Oversight

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

Not currently enrolling

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

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