Natural History of Amyloid Deposition in Adults With Down Syndrome

Down Syndrome Clinical Trial

Official title:

Natural History of Amyloid Deposition in Adults With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303133
• Other study ID #: PRO09080266
• Secondary ID: 2R01AG031110-03A
• Status: Completed
• Start date: August 2009
• Est. completion date: March 31, 2018

Study information

• Verified date: January 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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+.

Other known NCT identifiers

• NCT01412255

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Waisman Center at the University of Wisconsin - Madison	Madison	Wisconsin
United States	University of Pittsburgh and University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyloid deposition	Obtained via PiB PET scan	every 36 months for 9 years