DRKS00032459招募中不适用

Establishment of a biomaterial bank to study biomarkers in the context of neurodegenerative diseases.

Klinik für Psychiatrie und Psychotherapie, Universitätsmedizin Göttingen0 个研究点目标入组 2,000 人开始时间: 2023年9月11日最近更新: 2024年8月19日

适应症

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•Participation as a biomaterial donor in this study is possible if the following inclusion criteria are met:
•(a) a neurodegenerative disease or cognitive impairment is suspected or has been diagnosed,
•(b) there is central nervous disease or a suspicion of such disease without clinical evidence of a neurodegenerative component or cognitive impairment, if the indication for lumbar puncture is present.
•(c) In addition, control subjects may be allowed to participate in the study provided there is no suspicion of CNS disease.
•Subjects may be included only under the following conditions:
•(d) the respective subject (or a representative according to a legal authorization) agrees with biomaterial collections in terms of donation and storage as well as the subsequent analyses and is capable of this expression of intent
•(e) the subjects agree after sufficient information about the scientific background as well as the aims of the study and confirm this in writing in the consent form.

•Exclusion criteria for subjects are the following:
•(a) they do not consent to the blood and CSF donations and subsequent analyses.
•(b) There is a lack of capacity to consent of the proband without a legal representative (health care proxy or legal guardian) being available (blood and CSF donations).
•(c) there is accommodation in accordance with the Lower Saxony Law on Assistance and Protective Measures for the Mentally Ill (NPsychKG).
•(d) there is a known infectious disease. If an infectious disease is subsequently diagnosed, the corresponding samples are to be destroyed in accordance with the hygiene guidelines.
•(e) reliable data for diagnosis are not available and cannot be collected at reasonable cost to subjects and investigators.
•(f) there is oral anticoagulation (Marcumar or new oral anticoagulants) , which would lead to refraining from lumbar puncture or skin biopsy in the context of routine clinical diagnostics. Nevertheless, blood donation is possible in such a case.
•On the other hand, skin biopsy will only be performed in patients capable of giving consent.

发起方

Klinik für Psychiatrie und Psychotherapie, Universitätsmedizin Göttingen