ID

40322

Description

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/

Keywords

Versions (2)
  1. 3/23/20 3/23/20 -
  2. 4/8/20 4/8/20 - Sarah Riepenhausen
Copyright Holder

DZNE

Uploaded on

April 8, 2020

DOI

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License

Creative Commons BY-NC 4.0
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DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study

German

Eligibility criteria (Ein- und Ausschlusskriterien)

1 forms  
Administrative Daten
Description

Administrative Daten

Alias
UMLS CUI-1
C1320722
Studien ID
Description

Study ID

Data type

text

Alias
UMLS CUI [1]
C2826693
Visitendatum
Description

Tag Monat Jahr

Data type

date

Alias
UMLS CUI [1]
C1320303
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
Schriftliche Einwilligungserklärung
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Vorhandensein eines Informanten mit der Bereitschaft, im Verlauf der Studie Auskünfte über den Probanden / die Probandin zu geben
Description

Bitte beachten Sie: Der Informant darf gleichzeitig als Kontrollproband in DELCODE teilnehmen, sofern ein weiterer Informant vorhanden ist, der über sie/ihn Auskunft gibt.

Data type

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
Deutschkenntnisse, die eine Durchführung aller neuropsychologischen Tests erlauben.
Description

Sufficient knowledge of German, neuropsychological tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0205410
UMLS CUI [1,2]
C0376554
UMLS CUI [1,3]
C0017477
UMLS CUI [1,4]
C0027902
Alter >= 60 Jahre
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Einwilligungserklärung für Lumbalpunktion (optional)
Description

Informed consent for lumbar puncture

Data type

boolean

Alias
UMLS CUI [1,1]
C0037943
UMLS CUI [1,2]
C0021430
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI-1
C0680251
Fehlende Einwilligungsfähigkeit
Description

Unable to give consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
Umstände, die die protokollgerechte Teilnahme an der Studie erheblich behindern
Description

Conditions affecting protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
Umstände, die die Durchführung klinischer oder neuropsychologischer Untersuchungen behindern
Description

Condition affecting Clinical/ neuropsychological examination

Data type

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
Schwerwiegende sensorische Störungen (z.B. Blindheit oder Taubheit), welche die neuropsychologische Erhebung beeinträchtigen können
Description

Sensory disorders (e.g. blindness or deafness) affecting neuropsychological examination

Data type

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
Klinisch instabile oder schwerwiegende Erkrankung
Description

Clinical instable/ significant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
Aktuelle depressive Episode
Description

Current depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0349217
Psychotische oder bipolare Erkrankung oder Substanzabhängigkeit, aktuell oder in der Vorgeschichte
Description

Current/ medical history of Psychotic or bipolar disorder or substance dependency

Data type

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
Neurodegenerative Erkrankungen: außer AD
Description

Neurodegenerative diseases (except AD)

Data type

boolean

Alias
UMLS CUI [1,1]
C0524851
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0002395
Vaskuläre Demenz
Description

Vascular dementia

Data type

boolean

Alias
UMLS CUI [1]
C0011269
Schlaganfall in der Vorgeschichte mit Restsymptomatik
Description

History of stroke with residual symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0559159
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C1457887
Bekannte klinische signifikante pathologische Laborwerte (inkl. TSH, Vitamin B12)
Description

Clinical significant pathological laboratory values (incl. TSH, vitamin B12)

Data type

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
Aktuell in Behandlung befindliche oder die Lebenserwartung auf unter 2 Jahre reduzierte maligne Erkrankungen
Description

Current in treatment/ Life expectancy limiting malignant disease

Data type

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
Chronische Einnahme sedierender oder anticholinerger wirkender Psychopharmaka
Description

Chronic use of sedative/ anticholinergic psychotropic drugs

Data type

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
Einnahme antidementiver Medikation in den Gruppen SCD, gesunde Kontrollen und Angehörige, MCI (Ginkgo erlaubt)
Description

Use of anti-dementia medication excluding ginkgo

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3653789
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0330205
Teilnahme an einer klinischen Prüfung mit Antidementiva / kognitiv wirksamen Substanzen in den letzten 4 Wochen.
Description

Participation in a clinical trial with antidementia / cognitively active substances

Data type

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
Kontraindikationen bzgl. Lumbalpunktionen und MRT‐Untersuchungen
Description

Contraindications to lumbar punctures/ MRT examinations

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0037943
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Similar models

Eligibility criteria (Ein- und Ausschlusskriterien)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Daten
C1320722 (UMLS CUI-1)
Study ID
Item
Studien ID
text
C2826693 (UMLS CUI [1])
Date of Visit
Item
Visitendatum
date
C1320303 (UMLS CUI [1])
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
Informed consent
Item
Schriftliche Einwilligungserklärung
boolean
C0021430 (UMLS CUI [1])
Person who is willing to provide information about subject during the study
Item
Vorhandensein eines Informanten mit der Bereitschaft, im Verlauf der Studie Auskünfte über den Probanden / die Probandin zu geben
boolean
C0027361 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Sufficient knowledge of German, neuropsychological tests
Item
Deutschkenntnisse, die eine Durchführung aller neuropsychologischen Tests erlauben.
boolean
C0205410 (UMLS CUI [1,1])
C0376554 (UMLS CUI [1,2])
C0017477 (UMLS CUI [1,3])
C0027902 (UMLS CUI [1,4])
Age
Item
Alter >= 60 Jahre
boolean
C0001779 (UMLS CUI [1])
Informed consent for lumbar puncture
Item
Einwilligungserklärung für Lumbalpunktion (optional)
boolean
C0037943 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Ausschlusskriterien
C0680251 (UMLS CUI-1)
Unable to give consent
Item
Fehlende Einwilligungsfähigkeit
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Conditions affecting protocol compliance
Item
Umstände, die die protokollgerechte Teilnahme an der Studie erheblich behindern
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Condition affecting Clinical/ neuropsychological examination
Item
Umstände, die die Durchführung klinischer oder neuropsychologischer Untersuchungen behindern
boolean
C0348080 (UMLS CUI [1,1])
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])
Sensory disorders (e.g. blindness or deafness) affecting neuropsychological examination
Item
Schwerwiegende sensorische Störungen (z.B. Blindheit oder Taubheit), welche die neuropsychologische Erhebung beeinträchtigen können
boolean
C0152027 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0027902 (UMLS CUI [1,3])
C0456909 (UMLS CUI [2])
C0011053 (UMLS CUI [3])
Clinical instable/ significant disease
Item
Klinisch instabile oder schwerwiegende Erkrankung
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Current depressive episode
Item
Aktuelle depressive Episode
boolean
C0521116 (UMLS CUI [1,1])
C0349217 (UMLS CUI [1,2])
Current/ medical history of Psychotic or bipolar disorder or substance dependency
Item
Psychotische oder bipolare Erkrankung oder Substanzabhängigkeit, aktuell oder in der Vorgeschichte
boolean
C0521116 (UMLS CUI [1,1])
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])
Neurodegenerative diseases (except AD)
Item
Neurodegenerative Erkrankungen: außer AD
boolean
C0524851 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,3])
Vascular dementia
Item
Vaskuläre Demenz
boolean
C0011269 (UMLS CUI [1])
History of stroke with residual symptoms
Item
Schlaganfall in der Vorgeschichte mit Restsymptomatik
boolean
C0559159 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Clinical significant pathological laboratory values (incl. TSH, vitamin B12)
Item
Bekannte klinische signifikante pathologische Laborwerte (inkl. TSH, Vitamin B12)
boolean
C2826293 (UMLS CUI [1,1])
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])
Current in treatment/ Life expectancy limiting malignant disease
Item
Aktuell in Behandlung befindliche oder die Lebenserwartung auf unter 2 Jahre reduzierte maligne Erkrankungen
boolean
C0521116 (UMLS CUI [1,1])
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])
Chronic use of sedative/ anticholinergic psychotropic drugs
Item
Chronische Einnahme sedierender oder anticholinerger wirkender Psychopharmaka
boolean
C0205191 (UMLS CUI [1,1])
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])
Use of anti-dementia medication excluding ginkgo
Item
Einnahme antidementiver Medikation in den Gruppen SCD, gesunde Kontrollen und Angehörige, MCI (Ginkgo erlaubt)
boolean
C1524063 (UMLS CUI [1,1])
C3653789 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0330205 (UMLS CUI [1,4])
Participation in a clinical trial with antidementia / cognitively active substances
Item
Teilnahme an einer klinischen Prüfung mit Antidementiva / kognitiv wirksamen Substanzen in den letzten 4 Wochen.
boolean
C2348568 (UMLS CUI [1,1])
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])
Contraindications to lumbar punctures/ MRT examinations
Item
Kontraindikationen bzgl. Lumbalpunktionen und MRT‐Untersuchungen
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0037943 (UMLS CUI [2,2])
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