A pragmatic, multi-centre, double-blind, placebo controlled randomised trial to assess the safety, clinical and cost effectiveness of mirtazapine in patients with Alzheimer's Disease (AD) and agitated behaviours

niversity of Sussex0 sites247 target enrollmentJuly 28, 2016

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34688369/ (added 26/10/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37929672/ (added 06/11/2023)

Registry

who.int

Start Date

July 28, 2016

End Date

June 30, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Sussex

•1\. Aged 18 years and over
•2\. Clinical diagnosis of probable or possible Alzheimer’s Disease using National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria
•3\. A diagnosis of co\-existing agitated behaviours
•4\. Evidence that the agitated behaviours have not responded to management according to the AS/DH algorithm
•5\. If receiving cholinesterase inhibitors or memantine, must be on a stable dose (defined as three months on current dose)
•6\. A Cohen Mansfield Agitation Inventory score of 45 or greater
•7\. Written informed consent to enter and be randomised into the trial or consultee agreement for those without capacity
•8\. Availability of a suitable informant (consenting identifiable family carer or paid carer) to provide information on carer\-completed outcome measures and who consents to take part in the trial

•Current exclusion criteria as of 28/01/2019:
•1\. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
•2\. Contraindications to the administration of mirtazapine as per its current SmPCs
•3\. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias
•4\. Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)
•5\. Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH\>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
•Previous exclusion criteria:
•1\. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
•2\. Contraindications to the administration of carbamazepine and mirtazapine as per their current SmPCs
•3\. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias