Down Syndrome Biomarker Initiative (DSBI) (DSBI)
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|ClinicalTrials.gov Identifier: NCT02141971|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 2, 2017
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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.
|Condition or disease|
|Down Syndrome Alzheimer's Disease|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Down Syndrome Biomarker Initiative: A Natural History Study of Alzheimer's Disease in Down Syndrome (Pilot Study)|
|Actual Study Start Date :||June 1, 2013|
|Actual Primary Completion Date :||April 15, 2017|
|Actual Study Completion Date :||April 15, 2017|
Non-demented; Ages 30-40
Four non-demented Down syndrome patients between the ages of 30-40 years old
Non-demented; Ages 40-50
Four non-demented Down syndrome patients between the ages of 40-50 years old
Demented; Ages 50-60
Four demented Down syndrome patients between the ages of 50-60 years old
- Rate of decline as measured by cognitive, functional and behavioral tests [ Time Frame: 3 years ]
- Rate of conversion will be evaluated among all age groups [ Time Frame: 3 years ]
- Rate of volume change of whole brain, hippocampus, and other structural Magnetic resonance imaging (MRI) measures. [ Time Frame: 3 years ]
- Rates of change on each specified biochemical biomarkers [ Time Frame: 3 years ]
- Rates of change of glucose metabolism as measured by fluorodeoxyglucose positron emission tomography (FDG-PET) imaging [ Time Frame: 2 years ]
- Extent of amyloid deposition as measured amyloid PET imaging [ Time Frame: 3 years ]
- Rates of change on retinal amyloid measures. [ Time Frame: 3 years ]
- Correlations among biomarkers and cognitive change. [ Time Frame: 3 years ]
- Correlations of Tau deposition as measured by 18F-AV-1451 PET (Tau) imaging with other biomarkers [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||30 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141971
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Michael S. Rafii, MD, PhD||University of California, San Diego|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Michael Rafii, Associate Professor, University of California, San Diego|
|Other Study ID Numbers:||
|First Posted:||May 20, 2014 Key Record Dates|
|Last Update Posted:||May 2, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn