Natural History of Amyloid Deposition in Adults With Down Syndrome
Recruitment status was Recruiting
The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Natural History of Amyloid Deposition in Adults With Down Syndrome|
Trisomy 21 ApoE
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Adults with Down Syndrome ages 30+|
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+.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303133
|Contact: Sarah B Clayton, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh and University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15203|
|Contact: Sarah Clayton, BS 412-235-5485 email@example.com|
|United States, Wisconsin|
|Waisman Center at the University of Wisconsin - Madison||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Renee Makuch 608-262-4717 MAKUCH@Waisman.Wisc.Edu|
|Principal Investigator:||Benjamin Handen, PhD||University of Pittsburgh|