Effect of Pregabalin in Behavioral and psychological symptoms of dementia(BPSD)

Phase 3

• Conditions: ?Behavioral and psychological symptoms of dementia (BPSD).; Unspecified dementia with behavioral disturbance; F03.91

• Registration Number: IRCT20201201049553N1
• Lead Sponsor: Tehran University of Medical Sciences Deputy of Research and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Patients with dementia of the following types: Alzheimer's, vascular dementia or mixed vascular dementia, based on DSM V criteria
Patients with moderate to severe dementia based on the result of diagnostic tools such as FAST or MoCA

Exclusion Criteria

Other types of dementia such as Lewy body or frontotemporal dementia
History of major psychological disorders
History of drug abuse
History of epilepsy or other neurological disorders such as Multiple Sclerosis or head concussion which may exacerbate behavioral symptoms

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sum of score for Behavioural Pathology in Alzheimer's Disease questionnaire. Timepoint: Before Taking pregabalin, and 4,8,12 weeks after taking pregabalin. Method of measurement: Behavioural Pathology in Alzheimer's Disease questionnaire.;Sum of score for Neuropsychiatric Inventory questionnaire. Timepoint: Before Taking pregabalin, and 4,8,12 weeks after taking pregabalin. Method of measurement: Neuropsychiatric Inventory (NPI) questionnaire.

Secondary Outcome Measures

Name	Time	Method
Sum of score of dementia quality of life questionnaire. Timepoint: Before taking Pregabalin and on the weeks of 4,8,12 after taking pregabalin. Method of measurement: dementia quality of life (qol) questionnaire.