Evaluation of the effect of rivastigmine on decision making in mild cognitive impairment (MCI) patients by Cambridge Neuropsychological Test Automated Battery (CANTAB)

The effect of rivastigmine on decision-making power of mild cognitive impairment patients

This study is phase III, randomized, two armed, parallel, double blinded (volunteers and analysis team), active controlled, which is performed in 40 patients with mild cognitive impairment in Roozbeh Hospital.

This study is performed on patients with cognitive impairment referred to Roozbeh Hospital. Patients randomly receive rivastigmine or placebo twice daily for 3 months. The specific code of each patient is written on the research label of each pill package, which is opaque. If needed, the dose is increased by 1.5 mg every two weeks. Due to the similarity of the placebo and drug packages and also random codes which are used to identify them, the patients will not be informed about the type of drug they received. Also according to the identity codes of each patient the study data will be provided anonymously to the study results analysis team. Thus, the study is blinded for the patient and the evaluator.

Patients with mild cognitive impairment, which are diagnosed based on the Fast = 3 criterion, enter the study after obtaining informed consent. In case of major neurological disorder, history of seizures and bradycardia patients will not be able to enter the study.

Patients with mild cognitive impairment are randomly divided into two groups of drugs and placebo in two groups of 20 people. In the intervention group, patients treated with rivastigmine initially receive 1.5 mg capsules twice daily, which can be increased to 3 mg twice daily after 2 weeks, depending on the possible side effects and response to treatment. Increasing the dose of the drug is also applied in placebo.

Effect on decision making

Patient randomization is done online (sealedenvelope.com). Using 4 blocks (Permuted balance Block) for a total of 72 patients with a 1: 1 allocation ratio, this random chain and anonymous codes consisting of 2 letters and a number will be made. When random assignment is made, four letters (corresponding to the first two letters of the first name and the first two letters of the last name) are added to these codes. On the package of drugs, the research label and the relevant codes are already inserted according to the produced sequence.

This study is designed to be double-blind. Research labeling will be done on two products. All the drugs used in the study are in completely opaque packages and their lids will be packaged with a disposable label. This package contains the corresponding randomization code. In this way, patients and physicians evaluating the clinical outcome will not be aware of the allocation of patients in treatment groups. Finally, all data will be coded for analysis.

due to confidentiality