Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Va⦠(NCT04552041) | Clinical Trial Compass
CompletedPhase 3
Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.
Russia406 participantsStarted 2020-12-03
Plain-language 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).
Who can participate
Age range60 Years β 85 Years
SexALL
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Inclusion criteria
β. Subjects aged 60-85 years old inclusively.
β. Subjects with verified diagnosis of vascular dementia.
β. Presence of all the vascular dementia criteria according to NINDS-AIREN:
β. onset of dementia within 3 months of stroke;
β. sharp deterioration of cognitive functions; or fluctuating, stepwise progression of cognitive impairment.
β. Availability of permanent caregiver throughout the study (nurse or relatives).
β. Total Mini-Mental State Examination (MMSE) score - 10-24.
β. Total MoCA score \<26.
Exclusion criteria
β. Signs of intracerebral hemorrhage, brain tumours causing dementia.
β. Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration.
What they're measuring
1
Change in Mean Montreal Π‘ognitive Assessment (MoCA) Score
β. Injuries of head (S00-S09) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas.
β. Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.).
β. 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).
β. Mental retardation (F70-79).
β. Inflammatory lesions of the brain with persistent neurological deficit.