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Natural 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 February 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01303133
First received: February 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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
Down Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Natural History of Amyloid Deposition in Adults With Down Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Trisomy 21 ApoE


Estimated Enrollment: 64
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)
Groups/Cohorts
Adults with Down Syndrome ages 30+

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+.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Non-Demented Adults with Down Syndrome, ages 30 and above

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303133

Contacts
Contact: Sarah B Clayton, BS 412-235-5485 stefanchinsb@upmc.edu

Locations
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     stefanchinsb@upmc.edu    
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    
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
Principal Investigator: Benjamin Handen, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Benjamin Handen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01303133     History of Changes
Other Study ID Numbers: PRO09080266
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Down Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 21, 2013