Arterial Spin Labeling (ASL) MRI for Cognitive Decline
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|ClinicalTrials.gov Identifier: NCT01727622|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer's Disease||Drug: FDG-PET Other: ASL-MRI Procedure: Lumbar Puncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimized Arterial Spin Labeling MRI for Cognitive Decline|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||May 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
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 health
Other Name: fluorodeoxyglucose
Arterial-Spin Labeled MRI to examine cerebral blood flow
Other Name: Arterial Spin Labeling
Procedure: 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
- 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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727622
|United States, Pennsylvania|
|Penn Memory Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David A Wolk, MD||University of Pennsylvania|