Trials / Unknown
UnknownNCT00966017
Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 108 (estimated)
- Sponsor
- National Institute on Aging (NIA) · NIH
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
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 72 people with Down syndrome (DS), 36 non-demented and 36 with dementia, as well as 36 age-matched healthy controls. 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.
Conditions
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2009-08-26
- Last updated
- 2009-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00966017. Inclusion in this directory is not an endorsement.