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

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.

Sponsors

Lead Sponsor: Materia Medica Holding

Source Materia Medica Holding
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, severiry 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".

Overall Status Not yet recruiting
Start Date November 2020
Completion Date December 2023
Primary Completion Date December 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in mean Montreal Сognitive Assessment (MoCA) score 24 weeks
Secondary Outcome
Measure Time Frame
Change in mean NPI-С score 24 weeks
Change in mean Montreal Сognitive Assessment (MoCA) score 12 weeks
Change in mean Neuropsychiatric Inventory-Clinician (NPI-С) score 12 weeks
Mean Clinical Global Impression Efficacy Index (СGI-EI) score 24 weeks
Enrollment 406
Condition
Intervention

Intervention Type: Drug

Intervention Name: Prospecta

Description: Oral administration.

Arm Group Label: Prospecta

Other Name: MMH-MAP

Intervention Type: Drug

Intervention Name: Placebo

Description: Oral administration.

Arm Group Label: Placebo

Eligibility

Criteria:

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'Enseignement 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 hypointensive 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.

Gender: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pavel Kamchatnov, professor Principal Investigator V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia
Overall Contact

Last Name: Mikhail Putilovskiy, MD, PhD

Phone: +74952761575

Phone Ext.: 302

Email: [email protected]

Location
Facility: Contact: Investigator:
Arkhangelsk Regional Clinical Hospital/Neurological department | Arkhangelsk, 163045, Russian Federation Nina Khasanova, MD, PhD Nina Khasanova, MD, PhD Principal Investigator
Belgorod Regional Clinical Hospital of St. Joasaph/Neurological department | Belgorod, 308007, Russian Federation Janna Chefranova, MD, PhD Janna Chefranova, MD, PhD Principal Investigator
Hospital "Russian Railways - Medicine" of the city of Bryansk/Medical rehabilitation department | Bryansk, 241004, Russian Federation Marina Agafonova, MD, PhD Marina Agafonova, MD, PhD Principal Investigator
Sverdlovsk Regional Clinical Psychiatric Hospital | Ekaterinburg, 6620030, Russian Federation Anna Malakhova, MD, PhD Anna Malakhova, MD, PhD Principal Investigator
Kazan State Medical University/Department of Neurology and Rehabilitation | Kazan, 420012, Russian Federation Enver Bogdanov, Prof. Enver Bogdanov, Prof. Principal Investigator
City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department/1st neurological department | Moscow, 115516, Russian Federation Pavel Kamchatnov, Prof. Pavel Kamchatnov, Prof. Principal Investigator
Central Clinical Hospital of the Russian Academy of Sciences/Treatment and Diagnostic Center | Moscow, 117593, Russian Federation Oleg Tyurin, MD Oleg Tyurin, MD Principal Investigator
Privolzhsky Research Medical University/Department of Medical Rehabilitation | Nizhny Novgorod, 603005, Russian Federation Anna Belova, Prof. Anna Belova, Prof. Principal Investigator
Nizhny Novgorod Regional Clinical Hospital. N. A. Semashko/Outpatient department | Nizhny Novgorod, 603126, Russian Federation Elena Antipenko, Prof. Elena Antipenko, Prof. Principal Investigator
Orenburg Regional Clinical Psychiatric Hospital # 1/Psychoneurological dispensary | Orenburg, 460006, Russian Federation Elena Kryukova, MD Elena Kryukova, MD Principal Investigator
Pyatigorsk City Clinical Hospital # 2/Neurological department | Pyatigorsk, 357538, Russian Federation Gennadiy Mishin, MD Gennadiy Mishin, MD Principal Investigator
LLC "Treatment and reabilitation research center " PHOENIX "/Day hospital # 1 | Rostov-on-Don, 344000, Russian Federation Olga Bukhanovskaya, MD, PhD Olga Bukhanovskaya, MD, PhD Principal Investigator
Psychoneurological dispensary # 10/Medical rehabilitation department | Saint Petersburg, 190121, Russian Federation Ekaterina Smetannikova, MD, PhD Ekaterina Smetannikova, MD, PhD Principal Investigator
St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze/Medical Rehabilitation Department | Saint Petersburg, 192242, Russian Federation Igor Voznyuk, Prof. Igor Voznyuk, Prof. Principal Investigator
Psychoneurological dispensary # 5/Day hospital | Saint Petersburg, 195176, Russian Federation Lyubov Gluskina, MD Lyubov Gluskina, MD Principal Investigator
Leningrad Regional Clinical Hospital/Neurological department | Saint-Petersburg, 194291, Russian Federation Leonid Zaslavskiy, Prof. Leonid Zaslavskiy, Prof. Principal Investigator
Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological department for patients with cerebrovascular accident # 24 | Samara, 443096, Russian Federation Tatiana Lokshtanova, MD, PhD Tatiana Lokshtanova, MD, PhD Principal Investigator
Saratov State Medical University V. I. Razumovsky/Department of Neurology named after K.N. Tretyakov | Saratov, 410012, Russian Federation Oleg Kolokolov, MD, PhD Oleg Kolokolov, MD, PhD Principal Investigator
Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Somatogeriatric department #19 | Stavropol, 355038, Russian Federation Oleg Boyev, MD, PhD Oleg Boyev, MD, PhD Principal Investigator
Bashkir State Medical University/Department of Neurology | Ufa, 450008, Russian Federation Leyla Akhmadeyeva, Prof. Leyla Akhmadeyeva, Prof. Principal Investigator
Ulyanovsk Regional Clinical Hospital/Outpatient department | Ulyanovsk, 432063, Russian Federation Irina Greshnova, MD, PhD Irina Greshnova, MD, PhD Principal Investigator
Volgograd State Medical University/Department of Neurology, Neurosurgery with the Course of Medical Genetics | Volgograd, 400131, Russian Federation Olga Kurushina, Md, PhD Olga Kurushina, Md, PhD Principal Investigator
Vsevolozhsk clinical interdistrict hospital/Neurological department | Vsevolozhsk, 188643, Russian Federation Liya Lukinykh, MD Liya Lukinykh, MD Principal Investigator
Clinical Hospital # 2/Neurological department #1 | Yaroslavl, 150030, Russian Federation Marina Morzhukhina, MD Marina Morzhukhina, MD Principal Investigator
Location Countries

Russian Federation

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Prospecta

Type: Experimental

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.

Label: Placebo

Type: Placebo Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: double-blind placebo-controlled randomized

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov