Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02759887
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2016-04-15
Brief Title:
Relationship Between Down Syndrome DS and Alzheimers Disease AD
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Longitudinal Assessment of Amyloid Positron Emission Tomography PET Fludeoxyglucose F18 FDG PET Tau PET Magnetic Resonance Imaging MRI and Blood Spot Ribonucleic Acid RNA in Down Syndrome Individuals With and Without Alzheimers Dementia and Normal Controls
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In order to treat individuals with Down syndrome DS better and more efficiently and to gain more insights on its relation to Alzheimers disease AD a comprehensive understanding is needed for its progression in the early or preclinical phase using various biomarkers DS is a significant risk factor for the early development of AD with plaques and tangles typically developing by age 35 A better understanding is needed of early markers of the disease in DS patients Additionally the DS population represents a unique group - due to this elevated risk for AD - to examine biomarkers that may translate in general outside of the DS population to individuals at risk for developing late onset AD In this proposal the researchers will assess the longitudinal changes of various biomarkers in a cohort of individuals similar in design to the cross-sectional sectional study in the preliminary data
Detailed Description:
This study will recruit from three experimental groups 1The DS adult group will consist of 15 DS subjects aged 21 and older who do not qualify for the diagnosis of dementia at the beginning of the study 2The DSAD group will consist of 15 DS subjects aged 40 and older who do qualify for the diagnosis of dementia by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition DSM-IV criteria Diagnoses will be by standard consensus review of all cases 3Normal control NC adult will consist of 10 cognitively normal non-DS individuals age-matched to the DS group Blood will be collected to assess apolipoprotein E ApoE genotype Participation in the dried blood spot collection DBSC will be an optional sub-study Only participants andor their caregiverslegally authorized representatives indicating they wish to have DBSC performed on the consent will provide specimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None