The effect of adding Mirtazapine to quetiapine on reducing aggression in patients with Alzheimer's dementia

Evaluation of the effect of adding Mirtazapine to Quetiapine on reducing aggression in patients with Alzheimer's dementia

Clinical trial with control group, double-blind, randomized on 52 patients. Randomization using the software

Experimental study of double-blind randomized clinical trial Patients: Outpatients referred to the Alzheimer's Association Mafi Clinic and Razi Hospital Blind people: participant-evaluator-researcher-analyst Patients are treated with Quetiapine. After 2-4 weeks, the(Cohen-Mansfield Agitation Inventory ) Questionnaire is completed. Patients with a score of 45 or higher are randomly divided into intervention (A) and control (B) groups. Group A is given Mirtazapine in addition to Quetiapine and will continue until the 6th week. Group B is given placebo in addition to Quetiapine . Patients are followed up weekly for 6 weeks. Psychiatric symptoms were recorded based on the CMAI as well as the severity and stage of Dementia according to the (Mini–mental state examination) at the beginning of the study, the end of the 4th week and the 6th week, and in the 6th week the information is statistically analysed.

Inclusion criteria: patient with Alzheimer At least two years have passed since the onset of the disease, and the (Cohen-Mansfield Agitation Inventory ) test score is more than 45 Exclusion criteria : psychiatric, physical, and neurological disability with a significant impact on patients' cognition, mental retardation , alcohol and substance abuse in the previous 6 months, and other Psychiatric medication.

Intervention :100-150 mg of Quetiapine and Mirtazapine (84 mg at night, which reached 71 mg at night after one week) control :100-150 mg of Quetiapine and placebo

Agitation changes Aggression changes Dementia status

Unit randomization happens in the form of blocks consisting of four units. For all six possible permutations, the numbers are associated as below: 1(AABB), 2(ABAB), 3(ABBA), 4(BBAA), 5(BABA), 6(BAAB) . Using a random table, numbers are chosen among those 6 groups to designate the allocated treatment. To continue the process of randomization, a hidden label method was adopted to further encode the blocks. In this method, blocks are numbered using a sequence of random numbers, then the randomly assigned treatment (medicine) is put in each block. The cans/blocks are then handed over to executive agents. Researcher allocates patients to either intervention or standard treatment based on the order of their arrival/reception. Tools: Create a randomized sequence using four random encoded blocks for the participants of the study. Approach: Random selection of the blocks and reading the letters from right to left on labelled blocks based on random sequence. Blocks are of the same weight and shape and prepared by an independent researcher.

This clinical trial is blinded so that the participants, the clinician, , principle researcher ,data collector and outcome evaluator do not have any info about the assignment of individuals to the groups. The evaluation of the subjects is done by the external evaluator who is not involved in the research team. The main drug and placebo that are similar (in terms of odour, colour, shape and taste) are placed in similar cans having the same weight by a person who is not a member of the research team. Drugs are coded based on random sequence in two groups ( A) and (B) and they are numbred randomly. A unique code is assigned to each patient .The researcher provides the drug to the participant according to the coding