Down Syndrome Biomarker Initiative (DSBI)
Completed
Conditions studied: Down Syndrome, Alzheimer's Disease
In brief
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. Currently available longitudinal data in DS suggest a high rate of transition to dementia from the late 40s through the early 50s of these individuals. This, together with the universal presence of plaques in DS by their mid 40s makes this age range ideal for studying the development of AD.
Key facts
- Study ID
- NCT02141971
- Run by
- Michael Rafii
- People needed
- 12
- Starts
- 2013-06-01
- Expected to finish
- 2017-04-15
- Last updated by the study team
- 2017-05-02
Who can join
Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of Down Syndrome due to Trisomy 21.
- Subjects 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.
- Participant is able to speak/communicate.
- Subject is willing and has no contraindications to MRI scanning.
- Participant or parent/legal guardian provides consent.
- Participant must agree to allow for indefinite storage of his/her data and samples.
You may not qualify if…
- Patients who are anarthric or mute.
- Patients who do not meet the criteria for the diagnosis of DS.
- Patients unwilling or unable to participate in all tests and procedures.
- Unstable medical or behavioral issues.
- Unable or unwilling to perform MRI and/or PET imaging.
Where it is running
- University of California, San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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