Arterial Spin Labeling (ASL) MRI for Cognitive Decline

NCT ID: NCT01727622

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2018-05-31

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

FDG-PET

Intervention Type: DRUG

Diagnostic: FDG-PET imaging to examine neuronal health

ASL-MRI

Intervention Type: OTHER

Arterial-Spin Labeled MRI to examine cerebral blood flow

Lumbar Puncture

Intervention Type: PROCEDURE

Lumbar puncture to acquire a small amount of cerebrospinal fluid for protein level analyses. Note that this will not be required in all participants.

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.

FDG-PET

Intervention Type: DRUG

Diagnostic: FDG-PET imaging to examine neuronal health

ASL-MRI

Intervention Type: OTHER

Arterial-Spin Labeled MRI to examine cerebral blood flow

Lumbar Puncture

Intervention Type: PROCEDURE

Lumbar puncture to acquire a small amount of cerebrospinal fluid for protein level analyses. Note that this will not be required in all participants.

Interventions

FDG-PET

Diagnostic: FDG-PET imaging to examine neuronal health

Intervention Type: DRUG

ASL-MRI

Arterial-Spin Labeled MRI to examine cerebral blood flow

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Other Intervention Names

fluorodeoxyglucose; Arterial Spin Labeling; Spinal Tap

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Wolk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Memory Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

5R01AG040271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

815471

Identifier Type: -

Identifier Source: org_study_id