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Natural History of Amyloid Deposition in Adults With Down Syndrome

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01303133
Collaborator
National Institute on Aging (NIA) (NIH)
81
Enrollment
2
Locations
104
Duration (Months)
40.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    81 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Natural History of Amyloid Deposition in Adults With Down Syndrome
    Study Start Date :
    Aug 1, 2009
    Actual Primary Completion Date :
    Mar 31, 2018
    Actual Study Completion Date :
    Mar 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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+/+)

    Outcome Measures

    Primary Outcome Measures

    1. Amyloid deposition [every 36 months for 9 years]

      Obtained via PiB PET scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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?

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh and University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15203
    2 Waisman Center at the University of Wisconsin - Madison Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • University of Pittsburgh
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Benjamin Handen, PhD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin L Handen, PhD, BCBA-D, Principal Investigator, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01303133
    Other Study ID Numbers:
    • PRO09080266
    • 2R01AG031110-03A1
    • NCT01412255
    First Posted:
    Feb 24, 2011
    Last Update Posted:
    Jan 9, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Benjamin L Handen, PhD, BCBA-D, Principal Investigator, University of Pittsburgh
    beta amyloid, Down Syndrome, Alzheimer's Disease
    Additional relevant MeSH terms:
    Down Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jan 9, 2019