Arterial Spin Labeling (ASL) MRI for Cognitive Decline
This study is currently recruiting participants.
Verified November 2012 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Collaborator:
Information provided by (Responsible Party):
David Wolk, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01727622
First received: October 22, 2012
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mild Cognitive Impairment Alzheimer's Disease |
Drug: FDG-PET Other: ASL-MRI Procedure: Lumbar Puncture |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: FDG-PET
Diagnostic: FDG-PET imaging to examine neuronal health
Other: ASL-MRI
Arterial-Spin Labeled MRI to examine cerebral blood flow
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
|
Eligibility| Ages Eligible for Study: | 55 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males and females between the ages of 55 and 89.
- Fluent in English
- Part of the longitudinal cohort of the PMC/ADCC and have a study partner (for MCI patients only)
- Adequate visual and auditory acuity to allow for neuropsychological testing
- Good general health
- Women: post-menopausal or surgically sterile
- Willing and able to complete all required study procedures
- Completed 6 grades of education
- Geriatric Depression scale less than 6 (assessed within 3 months)
PATIENTS ONLY:
- Diagnosis of MCI
- MMSE between 24 and 30
Exclusion Criteria:
- Any significant neurological disease other than MCI
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign bodies in the eyes, skin, or body
- Occupational risks for ferrous metal in the eye
- Major depression, bipolar disorder, history of schizophrenia
- History of substance abuse or dependence within the past 2 years.
- Significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol
- Claustrophobia or other anxiety disorders
- Pregnancy
- Clinically relevant abnormalities in prior blood or urine samples including a blood glucose of ≥ 180 mg/dl
- Currently receiving medical or drug treatment contraindicating protocol participation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727622
Contacts
| Contact: Dasha Kliot, BA | 215-746-3949 | daria.kliot@uphs.upenn.edu |
| Contact: Lauren Mancuso, BA | 215-349-5903 | lauren.mancuso@uphs.upenn.edu |
Locations
| United States, Pennsylvania | |
| Penn Memory Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Dasha Kliot, BA 215-746-3949 daria.kliot@uphs.upenn.edu | |
| Principal Investigator: David A Wolk, MD | |
Sponsors and Collaborators
University of Pennsylvania
Investigators
| Principal Investigator: | David A Wolk, MD | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | David Wolk, Assistant Professor of Neurology, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01727622 History of Changes |
| Other Study ID Numbers: | 815471 |
| Study First Received: | October 22, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013