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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

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'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.