Natural History of Amyloid Deposition in Adults With Down Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Pittsburgh
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01303133
First received: February 22, 2011
Last updated: January 8, 2016
Last verified: January 2016

February 22, 2011
January 8, 2016
August 2009
June 2017   (final data collection date for primary outcome measure)
Amyloid deposition [ Time Frame: every 36 months ] [ Designated as safety issue: No ]
Obtained via PiB PET scan
Not Provided
Complete list of historical versions of study NCT01303133 on ClinicalTrials.gov Archive Site
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Natural History of Amyloid Deposition in Adults With Down Syndrome
Natural History of Amyloid Deposition in Adults With Down Syndrome
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.

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+.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
Trisomy 21 ApoE
Non-Probability Sample
Non-Demented Adults with Down Syndrome, ages 30 and above
Down Syndrome
Not Provided
Adults with Down Syndrome ages 30+
We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia.
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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
64
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
  2. Participant at least 30 years of age
  3. DSDS score indicating participant is asymptomatic for AD
  4. Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
  5. Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
  6. Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent

Exclusion Criteria:

  1. Participant is non-verbal or has extremely limited language skills
  2. Score within the "symptomatic" range on the DSDS
  3. Any significant disease or unstable medical condition that could affect neuropsychological testing
  4. Any problems with vision or hearing that could affect neuropsychological testing
  5. Participants in whom MRI is contraindicated
  6. Claustrophobia or prior failed experiences of completing MRI scans or blood draws
  7. Participant is pregnant or breast feeding
  8. History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?
Both
30 Years and older
Yes
Contact: Cathy J Wolfe, M.Ed. 412-235-5412 wolfec@upmc.edu
United States
 
NCT01303133
PRO09080266, 2R01AG031110-03A1
Yes
Not Provided
Not Provided
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Benjamin Handen, PhD University of Pittsburgh
University of Pittsburgh
January 2016

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