Clinical trial NCT03986424: Local Study of Akatinol Memantine in VaD in Russia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Dementia
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
Collaborators: name: LLC Merz Pharma, Russia
First posted: 2019-06-14
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Change from baseline in total ADAS-cog score points
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Mental Health Research Center"
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Neurology, Merz Investigational Site #0070008
city: Sankt-Peterburg
country: Russian Federation
facility: 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
Study officials:
affiliation: Merz Russia
name: Merz Russia Medical Expert
role: STUDY_DIRECTOR
References: