ID

41506

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 information about the PET investigation. It has to be filled in before PET study inclusion or before the PET follow-up examination.

Link

https://www.dzne.de/en/research/studies/clinical-studies/delcode/

Keywords

Versions (1)
  1. 10/30/20 10/30/20 -
Copyright Holder

DZNE (German Center for Neurodegenerative Diseases)

Uploaded on

October 30, 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 ( localization.languageCode.DE )

PET Investigation - In- and exclusion criteria

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
Visite
Description

Bitte geben Sie an, für welche Visite das vorliegende Dokument ausgefüllt werden soll.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
PET‐Untersuchungszeitpunkt:
Description

PET-Investigation - Point in time

Data type

integer

Alias
UMLS CUI [1,1]
C0439547
UMLS CUI [1,2]
C0032743
PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin
Description

PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C0220908
Durchführender Arzt / Ärztin:
Description

Name

Data type

text

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0032743
UMLS CUI [1,4]
C0220908
Arzt / Ärztin Nuklearmedizin:
Description

Falls beteiligt:

Data type

text

Alias
UMLS CUI [1,1]
C0028582
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0032743
UMLS CUI [1,4]
C0220908
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0032743
UMLS CUI-3
C0220908
Treffen die Subjective Cognitive Decline‐Kriterien aktuell zu?
Description

(Nur relevant für Baseline‐Untersuchung)

Data type

boolean

Alias
UMLS CUI [1,1]
C2266644
UMLS CUI [1,2]
C0338656
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C1706839
Sind aktuelle strukturelle MRT‐Aufnahmen aus DELCODE vorhanden?
Description

*Wenn „nein“ bei Follow‐Up: Rücksprache mit PET‐Studienkoordination!

Data type

integer

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0024485
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0032743
UMLS CUI-3
C0220908
Besteht aktuell ein Verlust der Geschäftsfähigkeit?
Description

Current loss of legal capacity

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C1517945
UMLS CUI [1,3]
C0683673
Verlust der Geschäftsfähigkeit: Anmerkungen?
Description

Current loss of legal capacity - Notes

Data type

text

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C1517945
UMLS CUI [1,3]
C0683673
UMLS CUI [1,4]
C0947611
Wurden bei dem/der Probanden/in innerhalb der vergangenen 10 Jahre Anwendungen von radioaktiven Stoffen oder ionisierender Strahlung zu Forschungs‐ oder Behandlungszwecken durchgeführt?
Description

(z.B. Strahlentherapie, Radio‐Iod‐Therapie bei Schilddrüsenerkrankungen; ausgenommen: vorherige PET‐ Untersuchungen im Rahmen der DELCODE‐PET‐Studie)

Data type

boolean

Alias
UMLS CUI [1,1]
C3843903
UMLS CUI [1,2]
C0242481
UMLS CUI [1,3]
C4086728
UMLS CUI [1,4]
C4699614
UMLS CUI [2,1]
C0034538
UMLS CUI [2,2]
C0242481
UMLS CUI [2,3]
C4086728
UMLS CUI [2,4]
C4699614
UMLS CUI [3,1]
C3843903
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C4086728
UMLS CUI [3,4]
C4699614
UMLS CUI [4,1]
C0034538
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C4086728
UMLS CUI [4,4]
C4699614
Bei Anwendungen von radioaktiven Stoffen oder ionisierender Strahlung zu Forschungs‐ oder Behandlungszwecken innerhalb der vergangenen 10 Jahre: Anmerkungen?
Description

(z.B. Strahlentherapie, Radio‐Iod‐Therapie bei Schilddrüsenerkrankungen; ausgenommen: vorherige PET‐ Untersuchungen im Rahmen der DELCODE‐PET‐Studie)

Data type

text

Alias
UMLS CUI [1,1]
C4048755
UMLS CUI [1,2]
C3843903
UMLS CUI [1,3]
C0242481
UMLS CUI [1,4]
C4086728
UMLS CUI [1,5]
C4699614
UMLS CUI [1,6]
C0947611
UMLS CUI [2,1]
C4048755
UMLS CUI [2,2]
C0034538
UMLS CUI [2,3]
C0242481
UMLS CUI [2,4]
C4086728
UMLS CUI [2,5]
C4699614
UMLS CUI [2,6]
C0947611
UMLS CUI [3,1]
C4048755
UMLS CUI [3,2]
C3843903
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C4086728
UMLS CUI [3,5]
C4699614
UMLS CUI [3,6]
C0947611
UMLS CUI [4,1]
C4048755
UMLS CUI [4,2]
C0034538
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C4086728
UMLS CUI [4,5]
C4699614
UMLS CUI [4,6]
C0947611
Leidet der/ die Proband/in aktuell unter insulinpflichtigem Diabetes?
Description

Current insulin-dependent diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0521116
Falls insulinpflichtiger Diabetes: Anmerkungen?
Description

Current insulin-dependent diabetes - Notes

Data type

text

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0683673
UMLS CUI [1,4]
C0947611
Leidet der/die Proband/in aktuell unter schweren Leberfunktionsstörungen (z.B. Zirrhose) oder dialysepflichtigen Niereninsuffizienzen?
Description

Current severe liver dysfunction or renal insufficiency requiring dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0011946
UMLS CUI [1,5]
C0521116
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521116
Bei schwerer Leberfunktionsstörung oder dialysepflichtiger Niereninsuffizienz - Anmerkungen?
Description

Current severe liver dysfunction or renal insufficiency requiring dialysis - Notes

Data type

text

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0011946
UMLS CUI [1,5]
C0521116
UMLS CUI [1,6]
C0947611
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521116
UMLS CUI [2,4]
C0947611
Wurden im vorausgegangenen MRT relevante Zufallsfunde berichtet?
Description

Relevant incidental findings in past MRI reported

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0743997
UMLS CUI [1,4]
C4319718
Im vorausgegangen MRT relevante Zufallsfunde - Anmerkungen?
Description

Relevant incidental findings in past MRI reported - Notes

Data type

text

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0743997
UMLS CUI [1,4]
C4319718
UMLS CUI [1,5]
C0947611
Ist der Proband/ die Probandin unfähig, 30‐40 Minuten ruhig zu liegen? (z.B. aufgrund von Rückenproblemen)
Description

Unable to lie still for 30-40 minutes

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0439654
UMLS CUI [1,4]
C0449238
Ist der Proband/ die Probandin unfähig, 30‐40 Minuten ruhig zu liegen? (z.B. aufgrund von Rückenproblemen) - Anmerkungen?
Description

Unable to lie still for 30-40 minutes - notes

Data type

text

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0439654
UMLS CUI [1,4]
C0449238
UMLS CUI [1,5]
C0947611
PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin
Description

PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C0220908
Besteht eine mündliche Einwilligung zur Teilnahme an der DELCODE‐PET‐Substudie?
Description

Oral consent to participate in the DELCODE-PET sub study

Data type

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C1511481
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0032743
UMLS CUI [1,5]
C2603343
Kann eine Terminvergabe erfolgen?
Description

Appointment allocation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003629
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C1272703
Sonstige Anmerkungen / Ergänzungen
Description

Other remarks / additions

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

PET Investigation - In- and exclusion criteria

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
Visite
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of visit
Code List
Visite
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
Baseline (0)
Item
PET‐Untersuchungszeitpunkt:
integer
C0439547 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
PET-Investigation - Point in time)
Code List
PET‐Untersuchungszeitpunkt:
CL Item
Baseline‐PET (P0) (1)
CL Item
Follow‐Up‐PET nach 24 Monaten (P24) (2)
Item Group
PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin
C0032743 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
PET- Screening: Performing physician
Item
Durchführender Arzt / Ärztin:
text
C0031831 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
PET-screening: Nuclear medicine specialist
Item
Arzt / Ärztin Nuklearmedizin:
text
C0028582 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
C0032743 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Subjective Cognitive Decline - Criteria
Item
Treffen die Subjective Cognitive Decline‐Kriterien aktuell zu?
boolean
C2266644 (UMLS CUI [1,1])
C0338656 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1706839 (UMLS CUI [1,4])
Item
Sind aktuelle strukturelle MRT‐Aufnahmen aus DELCODE vorhanden?
integer
C0521116 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Current structural MRI-Image available
Code List
Sind aktuelle strukturelle MRT‐Aufnahmen aus DELCODE vorhanden?
CL Item
Ja (1)
CL Item
Nein* (2)
Item Group
Ausschlusskriterien
C0680251 (UMLS CUI-1)
C0032743 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Current loss of legal capacity
Item
Besteht aktuell ein Verlust der Geschäftsfähigkeit?
boolean
C0521116 (UMLS CUI [1,1])
C1517945 (UMLS CUI [1,2])
C0683673 (UMLS CUI [1,3])
Current loss of legal capacity - Notes
Item
Verlust der Geschäftsfähigkeit: Anmerkungen?
text
C0521116 (UMLS CUI [1,1])
C1517945 (UMLS CUI [1,2])
C0683673 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Apply of radioactive materials or ionizing radiation for research or treatment purposes in past 10 years?
Item
Wurden bei dem/der Probanden/in innerhalb der vergangenen 10 Jahre Anwendungen von radioaktiven Stoffen oder ionisierender Strahlung zu Forschungs‐ oder Behandlungszwecken durchgeführt?
boolean
C3843903 (UMLS CUI [1,1])
C0242481 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,3])
C4699614 (UMLS CUI [1,4])
C0034538 (UMLS CUI [2,1])
C0242481 (UMLS CUI [2,2])
C4086728 (UMLS CUI [2,3])
C4699614 (UMLS CUI [2,4])
C3843903 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C4086728 (UMLS CUI [3,3])
C4699614 (UMLS CUI [3,4])
C0034538 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C4086728 (UMLS CUI [4,3])
C4699614 (UMLS CUI [4,4])
Apply of radioactive materials or ionizing radiation for research or treatment purposes in past 10 years? - Notes
Item
Bei Anwendungen von radioaktiven Stoffen oder ionisierender Strahlung zu Forschungs‐ oder Behandlungszwecken innerhalb der vergangenen 10 Jahre: Anmerkungen?
text
C4048755 (UMLS CUI [1,1])
C3843903 (UMLS CUI [1,2])
C0242481 (UMLS CUI [1,3])
C4086728 (UMLS CUI [1,4])
C4699614 (UMLS CUI [1,5])
C0947611 (UMLS CUI [1,6])
C4048755 (UMLS CUI [2,1])
C0034538 (UMLS CUI [2,2])
C0242481 (UMLS CUI [2,3])
C4086728 (UMLS CUI [2,4])
C4699614 (UMLS CUI [2,5])
C0947611 (UMLS CUI [2,6])
C4048755 (UMLS CUI [3,1])
C3843903 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C4086728 (UMLS CUI [3,4])
C4699614 (UMLS CUI [3,5])
C0947611 (UMLS CUI [3,6])
C4048755 (UMLS CUI [4,1])
C0034538 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C4086728 (UMLS CUI [4,4])
C4699614 (UMLS CUI [4,5])
C0947611 (UMLS CUI [4,6])
Current insulin-dependent diabetes
Item
Leidet der/ die Proband/in aktuell unter insulinpflichtigem Diabetes?
boolean
C0011854 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Current insulin-dependent diabetes - Notes
Item
Falls insulinpflichtiger Diabetes: Anmerkungen?
text
C0011854 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0683673 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Current severe liver dysfunction or renal insufficiency requiring dialysis
Item
Leidet der/die Proband/in aktuell unter schweren Leberfunktionsstörungen (z.B. Zirrhose) oder dialysepflichtigen Niereninsuffizienzen?
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0011946 (UMLS CUI [1,4])
C0521116 (UMLS CUI [1,5])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Current severe liver dysfunction or renal insufficiency requiring dialysis - Notes
Item
Bei schwerer Leberfunktionsstörung oder dialysepflichtiger Niereninsuffizienz - Anmerkungen?
text
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0011946 (UMLS CUI [1,4])
C0521116 (UMLS CUI [1,5])
C0947611 (UMLS CUI [1,6])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
Relevant incidental findings in past MRI reported
Item
Wurden im vorausgegangenen MRT relevante Zufallsfunde berichtet?
boolean
C0205156 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0743997 (UMLS CUI [1,3])
C4319718 (UMLS CUI [1,4])
Relevant incidental findings in past MRI reported - Notes
Item
Im vorausgegangen MRT relevante Zufallsfunde - Anmerkungen?
text
C0205156 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0743997 (UMLS CUI [1,3])
C4319718 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
Unable to lie still for 30-40 minutes
Item
Ist der Proband/ die Probandin unfähig, 30‐40 Minuten ruhig zu liegen? (z.B. aufgrund von Rückenproblemen)
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0439654 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Unable to lie still for 30-40 minutes - notes
Item
Ist der Proband/ die Probandin unfähig, 30‐40 Minuten ruhig zu liegen? (z.B. aufgrund von Rückenproblemen) - Anmerkungen?
text
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0439654 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
Item Group
PET‐Screening: Einschätzung durch Studienarzt/ ‐ärztin
C0032743 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Oral consent to participate in the DELCODE-PET sub study
Item
Besteht eine mündliche Einwilligung zur Teilnahme an der DELCODE‐PET‐Substudie?
boolean
C0442027 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0032743 (UMLS CUI [1,4])
C2603343 (UMLS CUI [1,5])
Appointment allocation
Item
Kann eine Terminvergabe erfolgen?
boolean
C0003629 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
Other remarks / additions
Item
Sonstige Anmerkungen / Ergänzungen
text
C0947611 (UMLS CUI [1])
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