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CLINICAL TRIAL article

Front. Neurosci.
Sec. Neuropharmacology
Volume 18 - 2024 | doi: 10.3389/fnins.2024.1460325

A randomized, double-blind, placebo-controlled clinical trial to evaluate pregabalin efficacy in the treatment of Behavioral and Psychological Symptoms of Dementia (BPSD) in Patients with Alzheimer's disease

Provisionally accepted
Leyla Maleki Leyla Maleki 1Fatemeh Mohammadian Fatemeh Mohammadian 2Mahsa Panahishokouh Mahsa Panahishokouh 3Niayesh Mohebbi Niayesh Mohebbi 1*
  • 1 Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Alborz, Iran
  • 2 Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran, Tehran, Iran
  • 3 Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran, Tehran, Iran

The final, formatted version of the article will be published soon.

    Abstract: Background: Behavioral and Psychological Symptoms of Dementia (BPSD) are common during Alzheimer's disease and cause severe problems for patients and their caregivers. Objectives: To assess the therapeutic efficacy of Pregabalin in comparison with a placebo in treating BPSD in patients with Alzheimer's disease (AD) visiting the memory and cognition clinic of Roozbeh Psychiatric Hospital in Tehran, Iran. Methods: A 12-week double-blind, randomized comparison of Pregabalin and placebo treatments was conducted in 53 patients with DSM-V diagnosis of dementia of Alzheimer's type. They were randomly assigned to receive Pregabalin (doses: 50 titrated up to 300 mg/day) or a placebo. Clinical response was evaluated using the Neuropsychiatric Inventory (NPI), and the Behavioral Pathology in AD Rating Scale (BEHAVE-AD) scores compared with baseline. Side effects were also recorded carefully. Results: Patients receiving Pregabalin had better outcomes in comparison with patients receiving a placebo regarding both NPI and BEHAVE-AD scores after 12 weeks (P-value = 0.009 for NPI and P-value = 0.003 for BEHAVE-AD). There was also a statistically significant decrease in the treatment group depression sub-score regarding NPI and BEHAVE-AD (respectively, P-value =0.000, 0.003). The caregiver burden sub-score of the NPI test was also lower in patients receiving pregabalin (P-value = 0.000). There was no statistically significant difference between the occurrence of adverse effects between the two groups (P-value = 1.00). Conclusion: Pregabalin at a dose of 300 mg/day was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms in patients with AD. Pregabalin could be considered a favorable choice for treating BPSD in adults with mild to moderate stages of Alzheimer 's-type dementia, considering its befitting safety profile. keywords: Pregabalin, behavioral and psychological symptoms, dementia

    Keywords: pregabalin, Dementia, Alzheimer's disease, Psychological symptoms, Behavioral Symptoms

    Received: 14 Jul 2024; Accepted: 11 Nov 2024.

    Copyright: © 2024 Maleki, Mohammadian, Panahishokouh and Mohebbi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Niayesh Mohebbi, Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Alborz, Iran

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.