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

Evaluating the effect of Pregabalin in treatment of Behavioral and psychological symptoms of dementia(BPSD)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201201049553N1
Enrollment
58
Registered
2021-07-08
Start date
2021-07-23
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

?Behavioral and psychological symptoms of dementia (BPSD). Unspecified dementia with behavioral disturbance

Interventions

Intervention 1: Intervention group: Patients in this group receive Pregabalin with the initial dose 50mg per day, the dose increases every week to the maximum of 150 mg twice a day for 12 weeks. Both

Sponsors

Tehran University of Medical Sciences Deputy of Research and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla maleki

Tehran University of Medical Sciences

l-maleki@student.tums.ac.ir+98 21 2269 2781

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026