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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

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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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