Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.
Vascular Dementia
About this trial
This is an interventional treatment trial for Vascular Dementia
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.
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
Experimental
Placebo Comparator
Prospecta
Placebo
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.