Health Condition 1: null- AGITATION AND/OR AGGRESSIVENESS IN ADULT AND ELDERLY PATIENTS WITH COGNITIVE IMPAIRMENT (DEMENTIA)
Conditions
Interventions
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, t
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with greater or equal to 25% reduction in MOSES irritability subscale scoreTimepoint: At the end of 21-day treatment period compared with baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 examinationTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
AGM-Medical Services
Outcome results
None listed