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NCT01727622 · ClinicalTrials.gov registry record
Arterial Spin Labeling (ASL) MRI for Cognitive Decline
A clinical trial, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 102
- Enrollment target
NCT01727622: Completed study, sponsored by University of Pennsylvania.
NCT01727622 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01727622 has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 102 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 th
Interventions
- PROCEDURE Lumbar Puncture
- DRUG FDG-PET
- OTHER ASL-MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2012-08 |
| Est. Completion | 2018-05-31 |
What the finished NCT01727622 record still lists
NCT01727622 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Lumbar Puncture is the first listed.
NCT01727622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01727622 about?
NCT01727622 is a clinical study titled "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...
What is the current status of trial NCT01727622?
This trial is currently completed. The enrollment target is 102 participants. The study started on 2012-08. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT01727622?
The interventions under investigation include: Lumbar Puncture (PROCEDURE), FDG-PET (DRUG), ASL-MRI (OTHER).
Who is sponsoring clinical trial NCT01727622?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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