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

Study ID: 30474
Short Title: Study of Mirtazapine or Carbamazepine for Agitation in Dementia
Organisation: Dorset Healthcare University NHS Foundation Trust
Location: Dorset Healthcare University NHS Foundation Trust
Condition: Dementia
Main Specialty: Dementias
Expected End Date: 31/08/2018
Postcode: BH1 4JQ
Contact Name: DHUFT Research & Development
Contact Email: dhc.research&development@nhs.net
Active: Yes

Inclusion Criteria

1. 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

2. A diagnosis of co-existing agitated behaviours

3. Evidence that the agitated behaviours have not responded to management according to the AS/DH algorithm

4. If receiving cholinesterase inhibitors or memantine, must be on a stable dose (defined as three months on current dose)

5. A Cohen Mansfield Agitation Inventory score of 45 or greater

6. Written informed consent to enter and be randomised into the trial or consultee agreement for those without capacity

7.  Availability of a suitable informant (consenting identifiable family carer or paid carer) to provide information on carercompleted outcome measures and who consents to take part in the trial

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

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.

Study summary:

This study is designed to establish the best treatment for the management of agitation and/or aggression in people with dementia. Agitation and aggression are common in people who suffer from dementia and can cause problems for the patients, families and the people caring for them. There are medicines available to treat agitation, but it is not clear which treatments work best for people with dementia. This study will compare 2 medicines with a placebo (a tablet designed to look like a medicine but that has no active component) to see if either are suitable for treating agitation in dementia. The study is divided into 3 parts: the consent and assessment part is likely take a few weeks; the treatment part will take 12 weeks; and the follow up part will continue to 12 months after treatment starts. Patients will be consented alongside a family or paid carer who is willing and able to consent to provide information for the study and to help the patient take the medication they will be given. Patients will continue to receive care from their doctors and other health and social services in the usual way whilst they are in the trial. The patient will be asked to take 1 tablet for the first 2 weeks of treatment in the trial, 2 tablets in the next 2 weeks and 3 tablets for the remaining 12 week treatment period (unless there are concerns about side effects resulting from them taking the medication). The patient, their carer, their doctors and the research workers will not know whether the patient is taking either of the active medications or the placebo until the end of the trial, although it is possible to find out which medicine they are taking in the event of a medical emergency.

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