ID

35842

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02141971

Nyckelord

  1. 2019-03-26 2019-03-26 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

Michael Rafii

Uppladdad den

26 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Study of Alzheimer's Disease in Down Syndrome NCT02141971

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

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.
Beskrivning

Age

Datatyp

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.
Beskrivning

Caregiver

Datatyp

boolean

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

Communication with the patient

Datatyp

boolean

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

Patient is able to have an MRI scanning

Datatyp

boolean

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

Informed consent of patient or parent/legal guardian

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients is anarthric or mute.
Beskrivning

Patient is not able to communicate verbally

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

The patient's general condition is unstable

Datatyp

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.
Beskrivning

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

Datatyp

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

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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