Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-28 @ 11:16 AM
Study NCT ID:
NCT00965835
Status:
UNKNOWN
Last Update Posted:
2009-12-29
First Post:
2009-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amyloid Plaque and Tangle Imaging in Alzheimer's Disease and Down Syndrome
Sponsor:
National Institute on Aging (NIA)
Organization:
Study Overview
Official Title:
Amyloid Plaque and Tangle Imaging in Alzheimer's Disease and Down Syndrome
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
RECRUITING
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:
The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid, to be used with positron emission tomography (PET) for early detection and treatment monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small molecule probes, in the form of novel fluorescent dyes with radioactive labels, will demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched persons who are cognitively intact.
Detailed Description:
This is a naturalistic study in which clinical evaluations and brain scans will be performed on 20 people with Down syndrome (DS) as well as 20 healthy controls across a range of ages. Participants will receive comprehensive clinical and neuropsychological assessments. PET and MRI scans will be performed at baseline and after two years of follow up. All participants will have blood drawn for APOE genotyping during their baseline evaluations. The intellectual range of participants with DS will be restricted to IQ scores of 45 to 60 (moderate range) to reduce variability, particularly due to extreme low levels of intellectual ability.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21AG030681-01A2 | NIH | None | https://reporter.nih.gov/quic… | View |