Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.

NCT04552041 | Completed Phase 3 Results

• 1 other identifier: MMH-MAP-003
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 33

Brief Summary

Study purpose: \- evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia. Study objectives:

• evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo groups after 24-weeks of treatment
• evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospekta and Placebo groups (including central nervous system AEs during therapy, their relationship with the study drug and other characteristics).

Conditions

Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Mean Montreal Сognitive Assessment (MoCA) Score

  MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.

  Baseline, 24 weeks

Secondary Outcomes (4)

• Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score

  Baseline, 24 weeks

• Change in Mean Montreal Сognitive Assessment (MoCA) Score

  Baseline, 12 weeks

• Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score

  Baseline, 12 weeks

• Mean Clinical Global Impression Efficacy Index (СGI-EI) Score

  After 24 weeks of the treatment.

Study Arms (2)

Prospekta

EXPERIMENTAL

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. The overall duration of treatment is 24 weeks.

Drug: Prospekta

Placebo

PLACEBO COMPARATOR

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. The overall duration of treatment is 24 weeks.

Drug: Placebo

Interventions

Prospekta DRUG

Oral administration.

Also known as: MMH-MAP

Prospekta

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 60-85 years old inclusively.
• Subjects with verified diagnosis of vascular dementia.
• Presence of all the vascular dementia criteria according to NINDS-AIREN:
• A. Presence of dementia, which is defined as a decline in cognitive function relative to the previous level of functioning, manifested by impairments in memory and two or more cognitive domains (orientation, attention, language, visuospatial functions, executive functions, motor control and praxis), preferably established during a clinical trial and confirmed by neuropsychological testing.
• The cognitive impairment must be so severe that it affects daily activity, reducing it independently of the physical consequences of the stroke.
• B. The presence of cerebrovascular disease, confirmed by signs of focal damage on neurological examination, such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, hemianopsia or dysarthria associated with stroke (either a history of stroke or absence of such anamnestic information), and neuroimaging (CT or MRI) signs of cerebrovascular disease, including multiple infarcts in the territory of large vessels, or a single infarction in a strategically important area (angular gyrus, thalamus, basal ganglia, or the territory of the anterior or posterior cerebral arteries), as well as multiple lacunae in the region of the basal ganglia or white matter, or significant damage to the periventricular white matter, or a combination of the above lesions.
• C. There is an association between dementia and cerebrovascular disease as follows:
• onset of dementia within 3 months of stroke;
• sharp deterioration of cognitive functions; or fluctuating, stepwise progression of cognitive impairment.
• 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 MRI confirming the diagnosis of vascular dementia within 1 year prior to enrollment (or brain MRI performed at enrollment visit).

You may not qualify if:

• 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) 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) schizophrenia, schizotypal and delusional disorders (F20-29).
• Mental retardation (F70-79).
• Inflammatory lesions of the brain with persistent neurological deficit.
• Malignant neoplasms.
• Previously diagnosed cardiovascular diseases with functional class IV (according to New York Heart Association, 1964).
• Unstable angina pectoris, myocardial infarction or ischemic stroke within the last 6 months.
• Female patients with childbearing potency.
• Allergy/intolerance of any of the study drugs components including secondary to lactase deficiency.
• Any conditions which, according to the investigator opinion, may interfere with the patient's participation in the study.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (33)

Northern State Medical University/Department of Family Medicine and Internal Medicine

Arkhangelsk, 163000, Russia

Location

Belgorod Regional Clinical Hospital of St. Joasaph/Neurological department

Belgorod, 308007, Russia

Location

Hospital "Russian Railways - Medicine" of the city of Bryansk/Medical rehabilitation department

Bryansk, 241004, Russia

Location

Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

Kazan State Medical University/Department of Neurology and Rehabilitation

Kazan', 420012, Russia

Location

City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department/1st neurological department

Moscow, 115516, Russia

Location

Peoples' Friendship University of Russia/Department of Psychiatry, Psychotherapy and Psychosomatic Pathology

Moscow, 117198, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences/Treatment and Diagnostic Center

Moscow, 117593, Russia

Location

Psychiatric hospital # 1 named after P.P. Kashchenko

Nikol’skoye, 188357, Russia

Location

Privolzhsky Research Medical University/Department of Medical Rehabilitation

Nizhny Novgorod, 603005, Russia

Location

Nizhny Novgorod Regional Clinical Hospital. N. A. Semashko/Outpatient department

Nizhny Novgorod, 603126, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital # 1/Psychoneurological dispensary

Orenburg, 460006, Russia

Location

Pyatigorsk City Clinical Hospital # 2/Neurological department

Pyatigorsk, 357538, Russia

Location

LLC "Treatment and reabilitation research center " PHOENIX "/Day hospital # 1

Rostov-on-Don, 344000, Russia

Location

Psychoneurological dispensary # 10/Medical rehabilitation department

Saint Petersburg, 190121, Russia

Location

St. Nicholas Psychiatric Hospital

Saint Petersburg, 190121, Russia

Location

St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze/Medical Rehabilitation Department

Saint Petersburg, 192242, Russia

Location

Leningrad Regional Clinical Hospital/Neurological department

Saint Petersburg, 194291, Russia

Location

Psychoneurological dispensary # 5/Day hospital

Saint Petersburg, 195176, Russia

Location

Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological department for patients with cerebrovascular accident # 24

Samara, 443096, Russia

Location

Saratov State Medical University V. I. Razumovsky/Department of Neurology named after K.N. Tretyakov

Saratov, 410012, Russia

Location

City Clinical Hospital # 2 named after V.I. Razumovsky

Saratov, 410028, Russia

Location

Saratov City Psychoneurological Dispensary

Saratov, 410038, Russia

Location

Regional Clinical Psychiatric Hospital of St. Sophia

Saratov, 410060, Russia

Location

Smolensk Regional Clinical Hospital

Smolensk, 214018, Russia

Location

Stavropol Regional Clinical Specialized Psychiatric Hospital # 1/Somatogeriatric department #19

Stavropol, 355038, Russia

Location

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, 450005, Russia

Location

Bashkir State Medical University/Department of Neurology

Ufa, 450008, Russia

Location

Ulyanovsk Regional Clinical Hospital/Outpatient department

Ulyanovsk, 432063, Russia

Location

Regional Clinic Hospital

Vladimir, 600023, Russia

Location

Volgograd State Medical University/Department of Neurology, Neurosurgery with the Course of Medical Genetics

Volgograd, 400131, Russia

Location

Vsevolozhsk clinical interdistrict hospital/Neurological department

Vsevolozhsk, 188643, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, 6620030, Russia

Location

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Study Officials

• Pavel Kamchatnov, professor

  V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind placebo-controlled randomized

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 17, 2020
• Study Start: December 3, 2020
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2023-01

Locations

RU (33)