Arterial Spin Labeling (ASL) MRI for Cognitive Decline
The purpose of this study is to determine the value of Arterial Spin Labeling (ASL) MRI, a measure of blood flow to the brain, in Mild Cognitive Impairment (MCI) and compare it to existing measures. In particular, the investigators will compare ASL MRI to Positron Emission Tomography (PET/CT), which measures brain metabolism reflecting how well cells in a patient's brain are functioning. In addition, the investigators will assess the relationship of these measures to specific protein levels associated with Alzheimer's Disease in the patient's cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) obtained by lumbar puncture. By comparing the information that is available from these procedures to the patient's performance on cognitive tests, the investigators hope to learn which procedures most accurately reflect and assist in determination of the potential causes of cognitive difficulties that arise with MCI, and thus, which are most useful in the clinical setting. In particular, PET scans have been found to be very useful in diagnosis of MCI and Alzheimer's Disease, but the investigators want to find out if they can get the same, or better, information from an ASL MRI scan, which is less expensive and easier to acquire.
Mild Cognitive Impairment
Procedure: Lumbar Puncture
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Optimized Arterial Spin Labeling MRI for Cognitive Decline|
- Composite region of interest (ROI) measure of cerebral blood flow (CBF) measured by ASL MRI versus composite ROI measure of cerebral metabolism measured by FDG PET [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Our primary aim is to determine if the diagnostic accuracy of 'state-of-the art' Arterial Spin Labeling (ASL) MRI is as good as (i.e., noninferior to) the diagnostic accuracy of FDG-PET/CT in comparison of MCI patients to cognitively normal adults. To test if ASL in noninferior to FDG-PET, we will use an asymptotic z test statistic for equivalent studies described in an equation of Zhou et al. (2002). The test statistic compares the AUCs from ASL and FDG-PET/CT by appropriately accounting for the correlation between them.
- Prediction of longitudinal change in hippocampal volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]Investigators will compare ASL MRI versus FDG PET in their ability to predict disease progression based on change in hippocampal volume. Investigators will define patients as 'progressors' if they display an atrophy rate greater than one standard deviation above the mean rate for healthy controls. Investigators will again use the composite ROI for ASL sequences and FDG-PET data to determine the best single or combination of predictors of progression.
- Prediction of longitudinal change in clinical status (i.e. progression to Alzheimer's Disease) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Investigators will compare ASL MRI versus FDG PET in their ability to predict disease progression based on conversion to clinical Alzheimer's Disease. Investigators will determine which measure best predicts conversion to clinical Alzheimer's Disease.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
No Intervention: Diagnostic Imaging
ASL-MRI and FDG-PET will be compared for ability to discriminate between Control subjects and adults with Mild Cognitive Impairment (prodromal AD). A lumbar puncture will be obtained in a proportion of the participants.
Diagnostic: FDG-PET imaging to examine neuronal healthOther: ASL-MRI
Arterial-Spin Labeled MRI to examine cerebral blood flowProcedure: Lumbar Puncture
Lumbar puncture to acquire a small amount of cerebrospinal fluid for protein level analyses. Note that this will not be required in all participants.
Other Name: Spinal Tap
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727622
|Contact: Grace Stockbower, BAemail@example.com|
|Contact: Lauren Mancuso, BAfirstname.lastname@example.org|
|United States, Pennsylvania|
|Penn Memory Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Dasha Kliot, BA 215-746-3949 email@example.com|
|Principal Investigator: David A Wolk, MD|
|Principal Investigator:||David A Wolk, MD||University of Pennsylvania|