A PROSPECTIVE, PHASE III, RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTICENTRE CLINICAL TRIAL OF TIAPRIDE TO EVALUATE ITS SAFETY AND EFFICACY IN THE TREATMENT OF AGITATION AND AGGRESSIVENESS IN ADULT AND ELDERLY PATIENTS WITH COGNITIVE IMPAIRMENT

Intas Pharmaceuticals Limited0 个研究点目标入组 240 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•(1) Adult and elderly patients (Age 50-90 years) of either sex*, diagnosed to be suffering from mild to moderate cognitive impairment due to dementia, with behavioral trouble in the form of agitation and/or aggressiveness, as substantiated by the Multidimensional Observational Scale for Elderly Subjects (MOSES) Irritability Subscale score ranging from 16 to 30
•[* In case of females: either post-menopausal, surgically sterile, or using a medically accepted means of contraception with a negative serum pregnancy test result]
•(2) Cognitively impaired cases should have the diagnosis of Alzheimer's disease, vascular dementia, or mixed dementia
•(3) Patients or his/her legally acceptable representative is willing to provide informed consent

•At least one of the items on MOSES Irritability Subscale rated 5 or no response at screening Acute psychosis Hyperprolactinemia Disease conditions augmented by increased prolactin levels Undergoing treatment with prohibited medications viz dopaminergic agonists drugs known to prolong QTc interval drugs causing bradycardia drugs causing electrolyte imbalance and certain psychotropic medications Clinically significant cardiac disorders Clinically significant seizure disorders History of alcohol or drug abuse within six months prior to screening Impaired hepatic function Pregnancy or lactation Known hypersensitivity to benzamide or butyrophenone group of drugs or to any components in their formulation Extrapyramidal symptoms History of cerebrovascular accident within previous 3 months Any other condition that in the opinion of the investigator renders the patient inappropriate for enrollment

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