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
National Institute on Aging (NIA)
Information provided by:
University of Pittsburgh Identifier:
First received: February 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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.

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:

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)
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+.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01303133

Contact: Sarah B Clayton, BS 412-235-5485

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   
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)
Principal Investigator: Benjamin Handen, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Benjamin Handen, University of Pittsburgh 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
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes processed this record on November 24, 2015