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Arterial Spin Labeling (ASL) MRI for Cognitive Decline

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01727622
First received: October 22, 2012
Last updated: March 29, 2017
Last verified: March 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    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 ]
    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.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: fluorodeoxyglucose
Other: ASL-MRI
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

  Eligibility

Ages Eligible for Study:   55 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 (must already be or agree to become a part of the Penn Memory Center cohort so baseline neuropsychological testing is available before study participation begins)
  • 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
  • Has a study partner

Exclusion Criteria:

  • Any contraindication to MRI (i.e. presence of pacemaker, ferrous metal in the eye, severe claustrophobia that would preclude subject from completing the MRI, etc.).
  • Major depression, bipolar disorder, history of schizophrenia
  • History of substance abuse or dependence within the past 2 years.
  • Any medical or neurological condition that, in the opinion of the investigator, would compromise the subject's safety, successful participation in, or integrity of the study.
  • Pregnancy
  • Recent history of poorly controlled diabetes (e.g. multiple blood glucose reports 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

Locations
United States, Pennsylvania
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Investigators
Principal Investigator: David A Wolk, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01727622     History of Changes
Other Study ID Numbers: 815471
5R01AG040271 ( US NIH Grant/Contract Award Number )
Study First Received: October 22, 2012
Last Updated: March 29, 2017

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

ClinicalTrials.gov processed this record on April 28, 2017