Natural History of Amyloid Deposition in Adults With Down... | NCT01303133

Studies
Natural History of Amyloid Deposition in Adults With Down Syndrome

NCT01303133

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 9, 2019Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Down Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R01AG031110-03A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Mar 31, 2018Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2019

Last Update Posted Date

Jan 9, 2019Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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+.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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+/+)

Interventions

Not provided

Measure	Description	Time Frame
Amyloid deposition	Obtained via PiB PET scan	every 36 months for 9 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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?

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Handen, PhD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh and University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15203	United States

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome
D058225	Plaque, Amyloid
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided