- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01727622
Arterial Spin Labeling (ASL) MRI for Cognitive Decline
September 25, 2020 updated by: University of Pennsylvania
Optimized Arterial Spin Labeling 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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Memory Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This project will focus on a population enriched in individuals with incipient AD (i.e.
MCI).
These subjects, as well as age-matched controls, will be recruited from the Alzheimer's Disease Center at the University of Pennsylania.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
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 Names:
Arterial-Spin Labeled MRI to examine cerebral blood flow
Other Names:
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 Names:
|
Mild Cognitive Impairment
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 Names:
Arterial-Spin Labeled MRI to examine cerebral blood flow
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
May 11, 2018
Study Completion (ACTUAL)
May 31, 2018
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
November 12, 2012
First Posted (ESTIMATE)
November 16, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 25, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- 815471
- 5R01AG040271 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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