ID
40322
Beschrijving
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/
Trefwoorden
Versies (2)
- 23-03-20 23-03-20 -
- 08-04-20 08-04-20 - Sarah Riepenhausen
Houder van rechten
DZNE
Geüploaded op
8 april 2020
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Einschlusskriterien
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Bitte beachten Sie: Der Informant darf gleichzeitig als Kontrollproband in DELCODE teilnehmen, sofern ein weiterer Informant vorhanden ist, der über sie/ihn Auskunft gibt.
Datatype
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
Beschrijving
Sufficient knowledge of German, neuropsychological tests
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205410
- UMLS CUI [1,2]
- C0376554
- UMLS CUI [1,3]
- C0017477
- UMLS CUI [1,4]
- C0027902
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Informed consent for lumbar puncture
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0037943
- UMLS CUI [1,2]
- C0021430
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Unable to give consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0332197
Beschrijving
Conditions affecting protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C0525058
Beschrijving
Condition affecting Clinical/ neuropsychological examination
Datatype
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
Beschrijving
Sensory disorders (e.g. blindness or deafness) affecting neuropsychological examination
Datatype
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
Beschrijving
Clinical instable/ significant disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C0443343
Beschrijving
Current depressive episode
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0349217
Beschrijving
Current/ medical history of Psychotic or bipolar disorder or substance dependency
Datatype
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
Beschrijving
Neurodegenerative diseases (except AD)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0524851
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0002395
Beschrijving
Vascular dementia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011269
Beschrijving
History of stroke with residual symptoms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0559159
- UMLS CUI [1,2]
- C1609982
- UMLS CUI [1,3]
- C1457887
Beschrijving
Clinical significant pathological laboratory values (incl. TSH, vitamin B12)
Datatype
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
Beschrijving
Current in treatment/ Life expectancy limiting malignant disease
Datatype
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
Beschrijving
Chronic use of sedative/ anticholinergic psychotropic drugs
Datatype
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
Beschrijving
Use of anti-dementia medication excluding ginkgo
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C3653789
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C0330205
Beschrijving
Participation in a clinical trial with antidementia / cognitively active substances
Datatype
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
Beschrijving
Contraindications to lumbar punctures/ MRT examinations
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0024485
- UMLS CUI [2,1]
- C1301624
- UMLS CUI [2,2]
- C0037943
Similar models
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])