Agitation and/or aggression in people with dementia Mental and Behavioural Disorders Unspecified dementia
Conditions
Interventions
Current interventions as of 28/01/2019:
Patients will be randomised in a 1:1 ratio to mirtazapine or placebo, stratified by study region and independent living using permuted block randomisation via a
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agitation is measured using the Cohen Mansfield Agitation Inventory (CMAI) long version, at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost effectiveness is assessed using a modified Client Service Receipt Inventory (CSRI), alongside information from DEMQOL and EQ-5D-5L interviews at baseline, 6 and 12 weeks 2. Agitation is measured using the CMAI score at 6 weeks (in addition to the primary outcome measure, as a secondary outcome measure) 3. Patient and carer quality of life is assessed via the Zarit carer burden, GHQ-12 and EQ-5D questionnaires at baseline, 6 and 12 weeks 4. Safety is assessed by looking at adverse events and adherence at 6 and 12 weeks. Adverse events are measured by face to face visits, follow up phone calls, review of medical records, notification by other health care professionals, blood and ECG test results and collection of a diary card which is completed by the patient/carer. Adherence is assessed by tablet counts, follow up phone calls and review of a diary card which is completed by the patient/carer, at week 2, 4, 6 and 12. Long term follow up takes place at 26 and 52 weeks and is assessed via a phone call: 1. Agitation is measured using CMAI 2. Institutionalisation is assessed using a study specific questionnaire 3. Mortality is measured using a study specific questionnaire 4. Clinical management is assessed using a study specific questionnaire | — |
Countries
England, United Kingdom
Contacts
Public ContactJuliet High
Outcome results
None listed