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History of Amyloid Deposition in Adults With Down Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01412255
First received: August 2, 2011
Last updated: August 5, 2011
Last verified: August 2011

August 2, 2011
August 5, 2011
December 2010
August 2012   (final data collection date for primary outcome measure)
Assessing presence of amyloid in functionally stable adults with DS [ Time Frame: Years 1 and 2 all participants will have brain function measures assessed during 2 visits to the site which may be consecutively or at convenience of participant. This conclude participant's participation in this study. ] [ Designated as safety issue: No ]
The primary objective of this proposal 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.
Same as current
Complete list of historical versions of study NCT01412255 on ClinicalTrials.gov Archive Site
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History of Amyloid Deposition in Adults With Down Syndrome
Natural History of Amyloid Deposition in Adults With Down Syndrome

The impact of a significant number of adults with Down syndrome developing Alzheimer's disease in their middle and later years is considerable in terms of the burden to family and caretakers, the effect on quality of life for the individual, as well as the costs for providing medical care. Consequently, identification of the nature, cause and outcome of decreased cognitive performance in adult Down syndrome individuals will be an essential component to improving the quality of life of this population.

Our research group at the University of Pittsburgh has recently developed a promising, non-invasive, in vivo PET tracer for imaging amyloid deposition in living humans. Known as Pittsburgh Compound-B (PiB), it has shown much promise in documenting pre-symptomatic amyloid deposition in living subjects destined to develop Alzheimer's disease (AD). PiB also provides a means to determine the natural history of amyloid deposition. While there has been increasing use of PiB to assess amyloid deposition in cognitively normal individuals, the fact remains that despite identifiable risk factors that increase the likelihood of acquiring AD (e.g., age, family history, ApoE4), we cannot identify with certainty those who will develop AD. This makes the study of pre-clinical amyloid deposition difficult in the general population. Conversely, individuals with Down syndrome (DS) are at high risk for developing AD due to the presence of an extra copy of chromosome 21, which codes for the Ab precursor protein (APP) gene. Post-mortem studies have documented the presence of AD pathology in 60 to 90% of adults with DS (with greater pathology increasing with age)(Additionally, symptoms of AD occur in over 40% for DS individuals between 50 and 59 years of age. Thus, the study of adults with DS provides a valuable opportunity to follow the natural history of amyloid deposition and compare it to clinical symptomatology - knowing that approximately half of the group will eventually develop clinical AD and an even greater fraction will develop amyloid deposits. Toward that end, the current multi-center proposal (University of Pittsburgh and University of Wisconsin) will document amyloid deposition in 64 non-demented/functionally stable adults with DS over a two-year period. We will study three age cohorts: 30-39 yrs, 40-49 yrs and >50 yrs. Subjects will also be assessed for the presence of the apolipoprotein-E4 (ApoE4) allele to determine its possible association with accelerated deposition brain amyloid. While we will not complete a natural history study of amyloid deposition in DS during the current project period, this effort will lay the foundation by gathering a valuable cohort of PiB+, non-demented DS subjects that we can follow beyond this grant period with future funding.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Adults ages 30 to over 50 years of age diagnosed with Down Syndrome

  • Down Syndrome
  • Amyloid Deposition
  • Alzheimers Disease
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Cohort 1 Adults with DS
Adults ages 30 to over 50 years of age
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with Down Syndrome over the age of 30 years.
Both
30 Years to 80 Years
No
Contact: Benjamin L Handen, PhD 412-235-5445 handenbl@upmc.edu
Contact: David Maloney, BA 412-235-5407 maloneyd2@upmc.edu
United States
 
NCT01412255
1R01AG31110-01A1
No
Benjamin L. Handen, PhD, University of Pittsburgh
University of Pittsburgh
University of Wisconsin, Madison
Not Provided
University of Pittsburgh
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP