Establishment of a biomaterial bank to study biomarkers in the context of neurodegenerative diseases.
- Conditions
- eurodegenerative diseases as well as healthy controls and controls with other psychiatric diseases.
- Registration Number
- DRKS00032459
- Lead Sponsor
- Klinik für Psychiatrie und Psychotherapie, Universitätsmedizin Göttingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2000
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomaterial bank assembly
- Secondary Outcome Measures
Name Time Method This comprehensively characterized biomaterial and data collection from patients with various neurodegenerative diseases as well as from subjects from suitable comparison groups will serve as an basis for scientific research projects on surrogate biomarkers, which in the long term will optimize the early and differential diagnosis of neurodegenerative and dementing diseases.