Natural History of Amyloid Deposition in Adults With Down Syndrome
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|ClinicalTrials.gov Identifier: NCT01303133|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : January 9, 2019
|Condition or disease|
Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and >50 years of age).
Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.
In addition, we will test the following secondary hypothesis:
Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.
Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.
|Study Type :||Observational|
|Actual Enrollment :||81 participants|
|Official Title:||Natural History of Amyloid Deposition in Adults With Down Syndrome|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
Adults with Down Syndrome ages 30+ (PiB-/-)
We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia.
|Adults with Down Syndrome ages 30+ (PiB-/+)|
|Adults with Down Syndrome ages 30+ (PiB+/+)|
- Amyloid deposition [ Time Frame: every 36 months for 9 years ]Obtained via PiB PET scan
Biospecimen Retention: Samples With DNA
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): NCT01303133
|United States, Pennsylvania|
|University of Pittsburgh and University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15203|
|United States, Wisconsin|
|Waisman Center at the University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Benjamin Handen, PhD||University of Pittsburgh|