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Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.

Primary Purpose

Vascular Dementia

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Prospecta
Placebo
Sponsored by
Materia Medica Holding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Dementia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects aged 60-85 years old.
  2. Subjects with verified diagnosis of vascular dementia.
  3. Presence of all the vascular dementia criteria according to National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enshrinement en Neurosciences (NINDS-AIREN) criteria:

    1. Cognitive disorder syndrome:

      • dysregulatory disorders: impaired aim formation, abstraction, initiation, planning, organization and maintenance of activities;
      • memory disorders (may be moderate) consisting in impaired reproduction against relatively retained recognition and efficacy of cues.
    2. Presence of a cerebrovascular disease:

      • according to brain imaging (expressed hypotensive irregular, "spotty", foci located periventricularly and in deep segments of white matter or diffuse symmetrical low-density changes in semioval center projection combined with at least one lacunar focus; lack of nonlacunar cortical or cortical-subcortical infarctions and signs of cerebral damage of another etiology);
      • focal symptoms in neurological status or their evidence in the history (hemiparesis, weakness of the lower part of facial muscles, Babinski's symptom, sensitivity disorders, dysarthria, gait disorders, extrapyramidal symptoms which may be explained by subcortical foci).
    3. Temporal relationship between dementia and cerebrovascular disorders (except for cases of subcortical vascular dementia): onset of dementia within 3-6 months post-stroke, sudden exacerbation of cognitive functions, step-wise progression of cognitive disorders.
  4. Availability of permanent caregiver throughout the study (nurse or relatives).
  5. Total Mini-Mental State Examination (MMSE) score - 10-24.
  6. Total MoCA score <26.
  7. Total NPI-C aggression and agitation domain score ≥14.
  8. Аbsence of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10).
  9. Brain Magnetic Resonance Imaging (MRI) confirming the diagnosis of vascular dementia within 1 year prior to enrollment (or brain MRI performed at enrollment visit).
  10. Subjects giving their consent to use reliable contraception throughout the study (for males).
  11. Availability of signed patient information sheet and informed consent form for participation in the clinical trial.

Exclusion Criteria:

  1. Signs of intracerebral hemorrhage, brain tumours causing dementia.
  2. Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration.
  3. Injuries of head (S00-S09 International Statistical Classification of Diseases and Related Health Problems (ICD)-10) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas.
  4. Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.).
  5. Other psychiatric diseases besides dementia: mental disorders and behavioral disorders due to use of psychoactive substances (F10-19 ICD-10), schizophrenia, schizotypal and delusional disorders (F20-29 ICD-10).
  6. Mental retardation(F70-79 ICD-10).
  7. Inflammatory lesions of the brain with persistent neurological deficit.
  8. Malignant neoplasms.
  9. Previously diagnosed cardiovascular diseases with functional class III or IV (according to New York Heart Association, 1964).
  10. Unstable angina pectoris, myocardial infarction or ischemic stroke within the last 6 months.
  11. Female with childbearing potential.
  12. Allergy/intolerance of any of the study product components including secondary to lactase deficiency.
  13. Any conditions which will prevent from the subject's participation in the study, according to investigator's opinion.
  14. History of treatment noncompliance, mental diseases, alcoholism or drug abuse which will prevent from following the study procedures, according to investigator's opinion.
  15. Participation in clinical trials for 3 months prior to enrollment in this study.
  16. The patient is the study site employee directly involved in the study, or is an immediate family member of the investigator or has another conflict of interests. Spouses, parents, children, or siblings, regardless of whether they are siblings or adopted are considered immediate family members.
  17. The patient works at "Materia Medica Holding", i.e. they are employees of the Company, temporary employees on a contract basis or appointed officials responsible for conduction of the study or their immediate family members.

Sites / Locations

  • Northern State Medical University/Department of Family Medicine and Internal Medicine
  • Belgorod Regional Clinical Hospital of St. Joasaph/Neurological department
  • Hospital "Russian Railways - Medicine" of the city of Bryansk/Medical rehabilitation department
  • Sverdlovsk Regional Clinical Psychiatric Hospital
  • Engels Psychiatric Hospital
  • Kazan State Medical University/Department of Neurology and Rehabilitation
  • City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department/1st neurological department
  • Peoples' Friendship University of Russia/Department of Psychiatry, Psychotherapy and Psychosomatic Pathology
  • Central Clinical Hospital of the Russian Academy of Sciences/Treatment and Diagnostic Center
  • Psychiatric hospital # 1 named after P.P. Kashchenko
  • Privolzhsky Research Medical University/Department of Medical Rehabilitation
  • Nizhny Novgorod Regional Clinical Hospital. N. A. Semashko/Outpatient department
  • Orenburg Regional Clinical Psychiatric Hospital # 1/Psychoneurological dispensary
  • Pyatigorsk City Clinical Hospital # 2/Neurological department
  • LLC "Treatment and reabilitation research center " PHOENIX "/Day hospital # 1
  • Psychoneurological dispensary # 10/Medical rehabilitation department
  • St. Nicholas Psychiatric Hospital
  • St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze/Medical Rehabilitation Department
  • Psychoneurological dispensary # 5/Day hospital
  • Leningrad Regional Clinical Hospital/Neurological department
  • Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological department for patients with cerebrovascular accident # 24
  • Saratov State Medical University V. I. Razumovsky/Department of Neurology named after K.N. Tretyakov
  • City Clinical Hospital # 2 named after V.I. Razumovsky
  • Saratov City Psychoneurological Dispensary
  • Regional Clinical Psychiatric Hospital of St. Sophia
  • Smolensk Regional Clinical Hospital
  • Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Somatogeriatric department #19
  • Republican Clinical Hospital named after G.G. Kuvatov
  • Bashkir State Medical University/Department of Neurology
  • Ulyanovsk Regional Clinical Hospital/Outpatient department
  • Regional Clinic Hospital
  • Volgograd State Medical University/Department of Neurology, Neurosurgery with the Course of Medical Genetics
  • Vsevolozhsk clinical interdistrict hospital/Neurological department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prospecta

Placebo

Arm Description

Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.

Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.

Outcomes

Primary Outcome Measures

Change in mean Montreal Сognitive Assessment (MoCA) score
Montreal Сognitive Assessment is used to evaluate changes in cognitive function. It assesses multiple cognitive domains: attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. Maximum score is 30; score ≥ 26 is considered to be normal.

Secondary Outcome Measures

Change in mean NPI-С score
Neuropsychiatric Inventory-Clinician (NPI-C) allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains evaluating frequency and severity of delusional ideas, hallucinations, agitation, aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behaviour, sleep and appetite disorders, aberrant vocalizations. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Total maximum score for all domains is 426.
Change in mean Montreal Сognitive Assessment (MoCA) score
Montreal Сognitive Assessment is used to evaluate changes in cognitive function. It assesses multiple cognitive domains: attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. Maximum score is 30; score ≥ 26 is considered to be normal.
Change in mean Neuropsychiatric Inventory-Clinician (NPI-С) score
Neuropsychiatric Inventory-Clinician (NPI-C) allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains evaluating frequency and severity of delusional ideas, hallucinations, agitation, aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behaviour, sleep and appetite disorders, aberrant vocalizations. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Total maximum score for all domains is 426.
Mean Clinical Global Impression Efficacy Index (СGI-EI) score
Clinical Global Impression Efficacy Index (CGI-EI). TheCGI-E is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.

Full Information

First Posted
September 10, 2020
Last Updated
January 20, 2023
Sponsor
Materia Medica Holding
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1. Study Identification

Unique Protocol Identification Number
NCT04552041
Brief Title
Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.
Official Title
Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study purpose: - evaluate safety and clinical efficacy of Prospecta in the treatment of cognitive, behavioural and psychiatric disorders in patients with vascular dementia. Study objectives: evaluate and compare changes in cognitive functions and in behavioural and psychiatric dementia symptoms in Prospecta and Placebo groups after 24-week therapy: evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospecta and Placebo groups (including central nervous system AEs during therapy, their relationship with the product and other characteristics).
Detailed Description
Design: a multicenter double blind placebo-controlled parallel-group randomized clinical trial. The study will enroll male and female subjects aged 60-85 years diagnosed with vascular dementia (verified at Visit 1 and diagnosed according to the criteria of The National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences - NINDS-AIREN). Severity of vascular dementia should be moderate or mild (10-24 points according to Mini-Mental State Examination - MMSE), without signs of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10). After signing patient information sheet (informed consent form), investigator will collect complaints and medical history, perform objective examination, record vital signs (blood pressure (BP), respiratory rate (RR), heart rate (HR)) and evaluate the compliance of the subject's diagnosis with NINDS-AIREN vascular criteria of dementia (Visit 1; from day -14 to day 1). The investigator will assess cognitive disorders using Mini-Mental State Examination (MMSE) and Montreal Сognitive Assessment (МоСА). The investigator will fill the Neuropsychiatric Inventory Сlinician (NPI-С), and СSDD scales. The subject will undergo brain MRI (unless brain MRI was held within the last 12 months prior to enrollment are available). Concomitant therapy and concurrent diseases and conditions will be recorded. If subject met inclusion criteria, he/she will be randomized to one of the two groups: group 1 will receive Prospecta 2 tablets twice daily; group 2 will receive Placebo using the study drug dosing regimen. Treatment duration will be 24 weeks during which 6 Visits will be made. At visits 2 and 3 (week 4±3 days and week 8±3 days) the investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety. At visit 4 (week 12±7 days) the investigator will collect complaints, record objective examination findings and vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety and compliance, issue the study product until the next visit. The investigator will fill MoCA and NPI-C. At visits 5 and 6 (week 16±3 days and week 20±3 days) the investigator will make a phone call and collect the complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety. At visit 7 (week 24±7 days) the investigator will collect complaints, perform objective examination, record vital signs, monitor the prescribed and concomitant therapy, evaluate therapeutic safety, evaluate compliance. The investigator will fill MоСА and Clinical Global Impression Efficacy Index (CGI-EI). The investigator will fill NPI-C. During the study the treatment for underlying medical conditions will be allowed with the exception of the drugs indicated in the section "Prohibited concomitant therapy".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
double-blind placebo-controlled randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospecta
Arm Type
Experimental
Arm Description
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Intervention Type
Drug
Intervention Name(s)
Prospecta
Other Intervention Name(s)
MMH-MAP
Intervention Description
Oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration.
Primary Outcome Measure Information:
Title
Change in mean Montreal Сognitive Assessment (MoCA) score
Description
Montreal Сognitive Assessment is used to evaluate changes in cognitive function. It assesses multiple cognitive domains: attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. Maximum score is 30; score ≥ 26 is considered to be normal.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in mean NPI-С score
Description
Neuropsychiatric Inventory-Clinician (NPI-C) allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains evaluating frequency and severity of delusional ideas, hallucinations, agitation, aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behaviour, sleep and appetite disorders, aberrant vocalizations. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Total maximum score for all domains is 426.
Time Frame
24 weeks
Title
Change in mean Montreal Сognitive Assessment (MoCA) score
Description
Montreal Сognitive Assessment is used to evaluate changes in cognitive function. It assesses multiple cognitive domains: attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation. Maximum score is 30; score ≥ 26 is considered to be normal.
Time Frame
12 weeks
Title
Change in mean Neuropsychiatric Inventory-Clinician (NPI-С) score
Description
Neuropsychiatric Inventory-Clinician (NPI-C) allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains evaluating frequency and severity of delusional ideas, hallucinations, agitation, aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behaviour, sleep and appetite disorders, aberrant vocalizations. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Total maximum score for all domains is 426.
Time Frame
12 weeks
Title
Mean Clinical Global Impression Efficacy Index (СGI-EI) score
Description
Clinical Global Impression Efficacy Index (CGI-EI). TheCGI-E is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged 60-85 years old. Subjects with verified diagnosis of vascular dementia. Presence of all the vascular dementia criteria according to National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enshrinement en Neurosciences (NINDS-AIREN) criteria: Cognitive disorder syndrome: dysregulatory disorders: impaired aim formation, abstraction, initiation, planning, organization and maintenance of activities; memory disorders (may be moderate) consisting in impaired reproduction against relatively retained recognition and efficacy of cues. Presence of a cerebrovascular disease: according to brain imaging (expressed hypotensive irregular, "spotty", foci located periventricularly and in deep segments of white matter or diffuse symmetrical low-density changes in semioval center projection combined with at least one lacunar focus; lack of nonlacunar cortical or cortical-subcortical infarctions and signs of cerebral damage of another etiology); focal symptoms in neurological status or their evidence in the history (hemiparesis, weakness of the lower part of facial muscles, Babinski's symptom, sensitivity disorders, dysarthria, gait disorders, extrapyramidal symptoms which may be explained by subcortical foci). Temporal relationship between dementia and cerebrovascular disorders (except for cases of subcortical vascular dementia): onset of dementia within 3-6 months post-stroke, sudden exacerbation of cognitive functions, step-wise progression of cognitive disorders. Availability of permanent caregiver throughout the study (nurse or relatives). Total Mini-Mental State Examination (MMSE) score - 10-24. Total MoCA score <26. Total NPI-C aggression and agitation domain score ≥14. Аbsence of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10). Brain Magnetic Resonance Imaging (MRI) confirming the diagnosis of vascular dementia within 1 year prior to enrollment (or brain MRI performed at enrollment visit). Subjects giving their consent to use reliable contraception throughout the study (for males). Availability of signed patient information sheet and informed consent form for participation in the clinical trial. Exclusion Criteria: Signs of intracerebral hemorrhage, brain tumours causing dementia. Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration. Injuries of head (S00-S09 International Statistical Classification of Diseases and Related Health Problems (ICD)-10) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas. Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.). Other psychiatric diseases besides dementia: mental disorders and behavioral disorders due to use of psychoactive substances (F10-19 ICD-10), schizophrenia, schizotypal and delusional disorders (F20-29 ICD-10). Mental retardation(F70-79 ICD-10). Inflammatory lesions of the brain with persistent neurological deficit. Malignant neoplasms. Previously diagnosed cardiovascular diseases with functional class III or IV (according to New York Heart Association, 1964). Unstable angina pectoris, myocardial infarction or ischemic stroke within the last 6 months. Female with childbearing potential. Allergy/intolerance of any of the study product components including secondary to lactase deficiency. Any conditions which will prevent from the subject's participation in the study, according to investigator's opinion. History of treatment noncompliance, mental diseases, alcoholism or drug abuse which will prevent from following the study procedures, according to investigator's opinion. Participation in clinical trials for 3 months prior to enrollment in this study. The patient is the study site employee directly involved in the study, or is an immediate family member of the investigator or has another conflict of interests. Spouses, parents, children, or siblings, regardless of whether they are siblings or adopted are considered immediate family members. The patient works at "Materia Medica Holding", i.e. they are employees of the Company, temporary employees on a contract basis or appointed officials responsible for conduction of the study or their immediate family members.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Kamchatnov, professor
Organizational Affiliation
V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern State Medical University/Department of Family Medicine and Internal Medicine
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Belgorod Regional Clinical Hospital of St. Joasaph/Neurological department
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Hospital "Russian Railways - Medicine" of the city of Bryansk/Medical rehabilitation department
City
Bryansk
ZIP/Postal Code
241004
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Psychiatric Hospital
City
Ekaterinburg
ZIP/Postal Code
6620030
Country
Russian Federation
Facility Name
Engels Psychiatric Hospital
City
Engels
ZIP/Postal Code
413124
Country
Russian Federation
Facility Name
Kazan State Medical University/Department of Neurology and Rehabilitation
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department/1st neurological department
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Peoples' Friendship University of Russia/Department of Psychiatry, Psychotherapy and Psychosomatic Pathology
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Central Clinical Hospital of the Russian Academy of Sciences/Treatment and Diagnostic Center
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Psychiatric hospital # 1 named after P.P. Kashchenko
City
Nikol'skoye
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
Privolzhsky Research Medical University/Department of Medical Rehabilitation
City
Nizhny Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Nizhny Novgorod Regional Clinical Hospital. N. A. Semashko/Outpatient department
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Psychiatric Hospital # 1/Psychoneurological dispensary
City
Orenburg
ZIP/Postal Code
460006
Country
Russian Federation
Facility Name
Pyatigorsk City Clinical Hospital # 2/Neurological department
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
LLC "Treatment and reabilitation research center " PHOENIX "/Day hospital # 1
City
Rostov-on-Don
ZIP/Postal Code
344000
Country
Russian Federation
Facility Name
Psychoneurological dispensary # 10/Medical rehabilitation department
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
St. Nicholas Psychiatric Hospital
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze/Medical Rehabilitation Department
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Psychoneurological dispensary # 5/Day hospital
City
Saint Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital/Neurological department
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological department for patients with cerebrovascular accident # 24
City
Samara
ZIP/Postal Code
443096
Country
Russian Federation
Facility Name
Saratov State Medical University V. I. Razumovsky/Department of Neurology named after K.N. Tretyakov
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
City Clinical Hospital # 2 named after V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Saratov City Psychoneurological Dispensary
City
Saratov
ZIP/Postal Code
410038
Country
Russian Federation
Facility Name
Regional Clinical Psychiatric Hospital of St. Sophia
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Somatogeriatric department #19
City
Stavropol
ZIP/Postal Code
355038
Country
Russian Federation
Facility Name
Republican Clinical Hospital named after G.G. Kuvatov
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Bashkir State Medical University/Department of Neurology
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital/Outpatient department
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Regional Clinic Hospital
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Volgograd State Medical University/Department of Neurology, Neurosurgery with the Course of Medical Genetics
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
Vsevolozhsk clinical interdistrict hospital/Neurological department
City
Vsevolozhsk
ZIP/Postal Code
188643
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.

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