View Clinical Trial (Medical Research Study)
Natural History of Amyloid Deposition in Adults With Down Syndrome
| City: |
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53705 |
| Conditions: |
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Down Syndrome |
| Purpose: |
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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.
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| Study Summary: |
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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+.
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| Criteria: |
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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?
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| NCT ID: |
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NCT01303133 |
| Primary Contact: |
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Principal Investigator
Benjamin Handen, PhD
University of Pittsburgh
Sarah B Clayton, BS
Phone: 412-235-5485
Email: stefanchinsb@upmc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Madison, Wisconsin 53705
United States
Renee Makuch
Phone: 608-262-4717
Email: MAKUCH@Waisman.Wisc.Edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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