Natural History of Amyloid Deposition in Adults With Down Syndrome

NCT01303133 | Completed DMC

• 2 other identifiers: PRO090802662R01AG031110-03A1
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Down Syndrome

Keywords

beta amyloid, Down Syndrome, Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Amyloid deposition

  Obtained via PiB PET scan

  every 36 months for 9 years

Study Arms (3)

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+/+)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
• Participant at least 30 years of age
• DSDS score indicating participant is asymptomatic for AD
• Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
• Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
• Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent

You may not qualify if:

• Participant is non-verbal or has extremely limited language skills
• Score within the "symptomatic" range on the DSDS
• Any significant disease or unstable medical condition that could affect neuropsychological testing
• Any problems with vision or hearing that could affect neuropsychological testing
• Participants in whom MRI is contraindicated
• Claustrophobia or prior failed experiences of completing MRI scans or blood draws
• Participant is pregnant or breast feeding
• 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?

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Pittsburgh and University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15203, United States

Location

Waisman Center at the University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Trisomy 21 ApoE

MeSH Terms

Conditions

Down Syndrome; Plaque, Amyloid; Alzheimer Disease

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benjamin Handen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 24, 2011
• Study Start: August 1, 2009
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (2)