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ID
35842
Description
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
Link
https://clinicaltrials.gov/show/NCT02141971
Keywords
Versions (2)
- 3/26/19 3/26/19 -
- 9/20/21 9/20/21 -
Copyright Holder
Michael Rafii
Uploaded on
March 26, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Study of Alzheimer's Disease in Down Syndrome NCT02141971
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Eligibility
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])
C0332187 (UMLS CUI [1,2])
Inability to communicate verbally
Item
Patients is anarthric or mute.
boolean
C0234517 (UMLS CUI [1])
C0278249 (UMLS CUI [2])
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])
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])
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])
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])
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])