Effects of enhanced dopaminergic neurotransmission on working memory training efficiency in the healthy elderly - A prospective, single center, randomized, double blind, placebo controlled, parallel group, phase II trial - REBOOT-II

Aging Research Center, Karolinska Institutet and Stockholm University0 个研究点目标入组 70 人开始时间: 2016年10月5日最近更新: 2018年3月19日

适应症

试验速览

暂无简介。

•Mini-Mental State Examination score >26;
•Aged between 65 and 75 years;
•Absence of medical or psychiatric conditions specified in the exclusion criteria;
•Signed informed consent;
•Right handedness;
•Fluent Swedish;
•Absence of colorblindness;
•No previous participation in studies of similar design;
•No trauma to the head with loss of consciousness for more than 10 min;
•No history of brain injuries;
•No hormonal imbalance diseases (e.g. Cushing’s syndrome);
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Glaucoma (any history);
•Any history of serious heart disease (myocardial infarction, arrhythmia, atrioventricular block);
•Serious problems with heart and blood vessels, systolic/diastolic blood pressure < 100/50 or >160/95; Heart Failure: NYHA > IB; Chronic Venous Disease CEAP > C2);
•Severe pulmonary diseases;
•Type I diabetes;
•Recent history (5 years) of stomach and duodenum ulcers;
•Liver diseases (e.g. hepatitis, liver failure);
•Bleeding of the stomach or intestines;
•Kidney diseases;
•Serious urination problems;
•Recent history (5 years) of malignant tumor or mole, melanoma;
•Major psychiatric disorders such as major depression, bipolar affective disorder, psychosis (risks of exacerbation of psychiatric symptoms). History of mild to moderate depression/anxiety is allowed (but not recent: 5 year cut-off);
•Patients with neurological (Parkinson's and other movement disorders, Alzheimer's disease, epilepsy) disorders will also be excluded, as the present project targets healthy elderly population;
•MRI contra-indications: metal body implants and pacemakers, cochlear implants, claustrophobia, weight over 120 kg;
•Hypersensitivity to pro-dopaminergic drugs;
•Hypersensitivity to citrus fruits/ascorbic acid;

发起方

Aging Research Center, Karolinska Institutet and Stockholm University