ID

35842

Descrizione

Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged 30-60 years old. This study will observe 3 different groups: four non-demented subjects between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and four demented subjects 50-60 years old. ODM derived from: https://clinicaltrials.gov/show/NCT02141971

collegamento

https://clinicaltrials.gov/show/NCT02141971

Keywords

versioni (2)
  1. 26/03/19 26/03/19 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

Michael Rafii

Caricato su

26 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Study of Alzheimer's Disease in Down Syndrome NCT02141971

Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of down syndrome due to trisomy 21.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3537167
Patient must have a study partner (parent or other reliable caregiver) who has at least 10 hours of contact and who agrees to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms.
Descrizione

Caregiver

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C2348568
Patient is able to speak/communicate.
Descrizione

Communication with the patient

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0564215
Patient is willing and has no contraindications to MRI scanning.
Descrizione

Patient is able to have an MRI scanning

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024485
Patient or parent/legal guardian provides consent
Descrizione

Informed consent of patient or parent/legal guardian

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0600634
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0023226
Patient must agree to allow for indefinite storage of his/her data and samples.
Descrizione

Patient must agree to allow for indefinite storage of his/her data and samples

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0242578
UMLS CUI [1,2]
C0332187
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients is anarthric or mute.
Descrizione

Patient is not able to communicate verbally

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0234517
UMLS CUI [2]
C0278249
Patient does not fulfill the criteria for the diagnosis of Down Syndrome
Descrizione

Patient needs to fulfill all criteria for the diagnosis of Down Syndrome

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0013080
Patient is unwilling or unable to participate in all tests and procedures.
Descrizione

Patient is unwilling or unable to participate in all tests and procedures

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
Patient has unstable medical or behavioral issues.
Descrizione

The patient's general condition is unstable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004927
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
Patient is unable or unwilling to perform MRI and/or PET imaging.
Descrizione

Patient is not able or unwilling to perform MRI or PET imaging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0032743
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0032743
UMLS CUI [4,2]
C0558080
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of down syndrome due to trisomy 21.
boolean
C0001779 (UMLS CUI [1])
C3537167 (UMLS CUI [2])
Caregiver
Item
Patient must have a study partner (parent or other reliable caregiver) who has at least 10 hours of contact and who agrees to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms.
boolean
C0085537 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Verbal communication
Item
Patient is able to speak/communicate.
boolean
C0564215 (UMLS CUI [1])
MRI
Item
Patient is willing and has no contraindications to MRI scanning.
boolean
C0024485 (UMLS CUI [1])
Informed consent
Item
Patient or parent/legal guardian provides consent
boolean
C0021430 (UMLS CUI [1])
C0600634 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Data privacy
Item
Patient must agree to allow for indefinite storage of his/her data and samples.
boolean
C0242578 (UMLS CUI [1,1])
C0332187 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Inability to communicate verbally
Item
Patients is anarthric or mute.
boolean
C0234517 (UMLS CUI [1])
C0278249 (UMLS CUI [2])
Diagnosis
Item
Patient does not fulfill the criteria for the diagnosis of Down Syndrome
boolean
C0011900 (UMLS CUI [1,1])
C0013080 (UMLS CUI [1,2])
Procedure compliance
Item
Patient is unwilling or unable to participate in all tests and procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Unstable general condition
Item
Patient has unstable medical or behavioral issues.
boolean
C0004927 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Body-imaging
Item
Patient is unable or unwilling to perform MRI and/or PET imaging.
boolean
C0024485 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0032743 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0032743 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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