Depression realted to Bio-Cognitive-Neurophysiological Markers in AD, MCI, and geriatric depression

Hallym University Medical Center- Chuncheon0 个研究点目标入组 600 人开始时间: 待定最近更新: 2019年6月17日

试验速览

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•Inclusion Criteria
•1. Patients aged 60 years and older at the time of informed consent
•2. Patients who meet the following diagnosis criteria
•1) Diagnosis of Alzheimer’s disease and Mild cognitive disorder
•- Patients who meet DSM-IV criteria and assessment via neuropsychological tests that used the Korean version of the Consortium to Establish a Registry for Alzheimer’s Disease Assessment Packet (CERAD-K)
•2). Diagnosis of depression
•1) AD patients who meet Olin’s diagnostic criteria for depression in AD
•2) MCI or elderly patients who meet DSM-IV and MINI-K
•3) Those who are able to decide voluntary participation in this clinical trial, agree in writing, and perform clinical procedures, including questionnaire preparation. However, if the patient is in a state where he or she can not make a voluntary decision due to a decline in cognitive function, a legal representative may decide to participate.

•Exclusion Criteria
•1) Patients who were taking any antidepressant medications within the previous 4 weeks
•2) Patients who show evidence of serious or unstable medical illnesses (eg, Heart failure, Angina pectoris, Myocardial infaction, Arteriosclerosis, diabetes mellitus, inflammatory disease, malignant tumor) or serious mental illness.
•3) Patients who have a history of brain cramps, brain surgery, natural brain disease, or temperamental affective disorder, and abnormal findings other than brain atrophy in brain fMRI
•4) Patients who have a history of hypersensitivity to the investigational drug
•5) Patients who have treated with memantine medication
•6) Patients who were participated in other clinical trials within 3 months
•7) Patients with AST (GOT) or ALT (GPT) > 2 times the upper normal limit or serum creatinine exceeding 150 umol /L(1.7 mg/dL)
•8) Patients who have a history of alcohol or other substance dependence
•9) Patients who have evidence of uncontrolled diabetes mellitus or hypertension
•10) Patients who is deemed inapropriated for the trial by investigator
•11) Patients who have serious serious dementia (GDS score ? 7 or CDR ? 4)

发起方

Hallym University Medical Center- Chuncheon