ID
40322
Beschreibung
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Eligibility criteria. It has to be filled in at the baseline of the study.
Link
https://www.dzne.de/en/research/studies/clinical-studies/delcode/
Stichworte
Versionen (2)
- 23.03.20 23.03.20 -
- 08.04.20 08.04.20 - Sarah Riepenhausen
Rechteinhaber
DZNE
Hochgeladen am
8. April 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study
Eligibility criteria (Ein- und Ausschlusskriterien)
- StudyEvent: ODM
Beschreibung
Einschlusskriterien
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Bitte beachten Sie: Der Informant darf gleichzeitig als Kontrollproband in DELCODE teilnehmen, sofern ein weiterer Informant vorhanden ist, der über sie/ihn Auskunft gibt.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027361
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1997894
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C2347804
Beschreibung
Sufficient knowledge of German, neuropsychological tests
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205410
- UMLS CUI [1,2]
- C0376554
- UMLS CUI [1,3]
- C0017477
- UMLS CUI [1,4]
- C0027902
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Informed consent for lumbar puncture
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0037943
- UMLS CUI [1,2]
- C0021430
Beschreibung
Ausschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Unable to give consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0332197
Beschreibung
Conditions affecting protocol compliance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C0525058
Beschreibung
Condition affecting Clinical/ neuropsychological examination
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C1456356
- UMLS CUI [2,1]
- C0348080
- UMLS CUI [2,2]
- C0392760
- UMLS CUI [2,3]
- C0027902
Beschreibung
Sensory disorders (e.g. blindness or deafness) affecting neuropsychological examination
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0152027
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C0027902
- UMLS CUI [2]
- C0456909
- UMLS CUI [3]
- C0011053
Beschreibung
Clinical instable/ significant disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C0443343
Beschreibung
Current depressive episode
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0349217
Beschreibung
Current/ medical history of Psychotic or bipolar disorder or substance dependency
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0005586
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0005586
- UMLS CUI [3,1]
- C0521116
- UMLS CUI [3,2]
- C0033975
- UMLS CUI [4,1]
- C0262926
- UMLS CUI [4,2]
- C0033975
- UMLS CUI [5,1]
- C0521116
- UMLS CUI [5,2]
- C0038580
- UMLS CUI [6,1]
- C0262926
- UMLS CUI [6,2]
- C0038580
Beschreibung
Neurodegenerative diseases (except AD)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0524851
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0002395
Beschreibung
Vascular dementia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011269
Beschreibung
History of stroke with residual symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0559159
- UMLS CUI [1,2]
- C1609982
- UMLS CUI [1,3]
- C1457887
Beschreibung
Clinical significant pathological laboratory values (incl. TSH, vitamin B12)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2826293
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C1254595
- UMLS CUI [2,1]
- C0332257
- UMLS CUI [2,2]
- C0202230
- UMLS CUI [3,1]
- C0332257
- UMLS CUI [3,2]
- C0202252
Beschreibung
Current in treatment/ Life expectancy limiting malignant disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0442867
- UMLS CUI [2,1]
- C0023671
- UMLS CUI [2,2]
- C0439801
- UMLS CUI [2,3]
- C0442867
Beschreibung
Chronic use of sedative/ anticholinergic psychotropic drugs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205191
- UMLS CUI [1,2]
- C0036557
- UMLS CUI [1,3]
- C0033978
- UMLS CUI [2,1]
- C0205191
- UMLS CUI [2,2]
- C0242896
- UMLS CUI [2,3]
- C0033978
Beschreibung
Use of anti-dementia medication excluding ginkgo
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C3653789
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C0330205
Beschreibung
Participation in a clinical trial with antidementia / cognitively active substances
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C3653789
- UMLS CUI [2,1]
- C2348568
- UMLS CUI [2,2]
- C0008976
- UMLS CUI [2,3]
- C0009240
- UMLS CUI [2,4]
- C0205177
- UMLS CUI [2,5]
- C0439861
Beschreibung
Contraindications to lumbar punctures/ MRT examinations
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0024485
- UMLS CUI [2,1]
- C1301624
- UMLS CUI [2,2]
- C0037943
Ähnliche Modelle
Eligibility criteria (Ein- und Ausschlusskriterien)
- StudyEvent: ODM
C1533716 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0376554 (UMLS CUI [1,2])
C0017477 (UMLS CUI [1,3])
C0027902 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0027902 (UMLS CUI [2,3])
C0392760 (UMLS CUI [1,2])
C0027902 (UMLS CUI [1,3])
C0456909 (UMLS CUI [2])
C0011053 (UMLS CUI [3])
C2826293 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0349217 (UMLS CUI [1,2])
C0005586 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0005586 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0033975 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0033975 (UMLS CUI [4,2])
C0521116 (UMLS CUI [5,1])
C0038580 (UMLS CUI [5,2])
C0262926 (UMLS CUI [6,1])
C0038580 (UMLS CUI [6,2])
C0332300 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,3])
C1609982 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1521733 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C0332257 (UMLS CUI [2,1])
C0202230 (UMLS CUI [2,2])
C0332257 (UMLS CUI [3,1])
C0202252 (UMLS CUI [3,2])
C0087111 (UMLS CUI [1,2])
C0442867 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0442867 (UMLS CUI [2,3])
C0036557 (UMLS CUI [1,2])
C0033978 (UMLS CUI [1,3])
C0205191 (UMLS CUI [2,1])
C0242896 (UMLS CUI [2,2])
C0033978 (UMLS CUI [2,3])
C3653789 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0330205 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C3653789 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0009240 (UMLS CUI [2,3])
C0205177 (UMLS CUI [2,4])
C0439861 (UMLS CUI [2,5])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0037943 (UMLS CUI [2,2])