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Arterial Spin Labeling (ASL) MRI for Cognitive Decline

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Wolk, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01727622
First received: October 22, 2012
Last updated: June 30, 2013
Last verified: June 2013
  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
  • 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
  • Severe claustrophobia that would preclude subject from completing the MRI
  • 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 e.g. anticoagulants such as Coumadin/Warfarin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727622

Contacts
Contact: Grace Stockbower, BA 215-746-3949 grace.stockbower@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: June 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014