CLINICAL TRIAL OF TIAPRIDE TO EVALUATE ITS SAFETY AND EFFECTIVENESS IN THE TREATMENT OF AGITATION AND AGGRESSIVENESS IN ADULT AND ELDERLY PATIENTS WITH IMPAIRED HIGHER MENTAL FUNCTIONS

INTERVENTION: Intervention1: Tiapride 50mg conventional oral tablets: 1 tablet orally twice daily for first 3 days and if well tolerated, 1 tablet thrice daily thereafter, and if otherwise, same dosage continued, to complete 21 days Control Intervention1: Haloperidol 1.5mg conventional oral tablets: 1 tablet orally twice daily for first 3 days and if well tolerated, 1 tablet thrice daily thereafter, and if otherwise, same dosage continued, to complete 21 days CONDITION: AGITATION AND/OR AGGRESSIVENESS IN ADULT AND ELDERLY PATIENTS WITH COGNITIVE IMPAIRMENT (DEMENTIA) PRIMARY OUTCOME: Number of patients with greater or equal to ; 25% reduction in MOSES irritability subscale score‐‐‐‐‐‐Timepoint: At the end of 21‐day treatment period compared with baseline SECONDARY OUTCOME: No of patients with similar MMSE scores at study entry and end of study No of patients with SAS global mean score increased to more than 0.65 No of patients with BAS global item score increased to more or equal to 2 Any adverse event (other than neuroleptic drug‐induced extrapyramidal side effects and akathisia) reported voluntarily, observed, or noted on enquiry during the study period Any clinically significant change in laboratory investigation values, vital signs, and physical examination‐‐‐‐‐‐Timepoint: At the end of 21‐day treatment period compared with baseline Anytime during the study treatment compared with baseline Anytime during the study treatment compared with baseline Anytime during the study treatment compared with baseline Anytime during the study treatment compared with baseline INCLUSION CRITERIA: (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