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Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL) (CASL)

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ClinicalTrials.gov Identifier: NCT00880555
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : March 24, 2016
Last Update Posted : March 24, 2016
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan.

Condition or disease
Alzheimer Disease Dementia

Detailed Description:
Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan. Participants will undergo a single MRI scan, baseline financial capacity instrument (FCI) and cognitive evaluation, and then will be followed approximately annually to repeat the functional and cognitive assessments. Linear mixed effects models will be used to fit a model predicting financial capacity based on baseline cognitive tests. Measures from the MRI scan will be added to the model to determine whether imaging improves the predictions.
Study Design
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Study Type : Observational
Actual Enrollment : 78 participants
Time Perspective: Prospective
Official Title: Semantic Memory, Financial Capacity and Brain Perfusion in MCI
Study Start Date : April 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Arm 1: Non-Dementia Memory Disorder
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
Arm 2: Control
Elderly controls without memory impairment
Arm 3: Mild Alzheimer Disease
Patients with mild Alzheimer disease (but preserved routine activities of daily living)


Outcome Measures
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Primary Outcome Measures :
  1. FCI Score at Follow-up [ Time Frame: Year 1, Year 2, Year 3 ]
    At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.


Biospecimen Retention:   None Retained
N/A- no biospecimens

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
160 subjects are anticipated, with the expectation that initial cognitive evaluations will exclude about 60 subjects. We intend to maintain and follow 100 subjects, 40 with non-dementia memory impairment (meeting criteria for amnestic MCI) and 40 with no cognitive impairment, and 20 with mild Alzheimer disease
Criteria

Inclusion Criteria:

  • Veteran or non-veteran
  • Age 50-89
  • With normal cognition or memory impairment (MCI or mild AD)
  • English speaking
  • Right handed
  • Adequate vision and hearing to take part in tests
  • Able and willing to undergo MRI scan
  • Medically and psychiatrically stable
  • No other brain disease (such as tumor, Parkinson's disease, major stroke)

Exclusion Criteria:

  • Pregnancy
  • Inability to tolerate MRI (due to metal in body or claustrophobia)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880555


Locations
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United States, Alabama
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
VA Office of Research and Development
University of Alabama at Birmingham
Investigators
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Principal Investigator: David G Clark, MD Birmingham VA Medical Center, Birmingham, AL
More Information
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Publications of Results:

Other Publications:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00880555    
Other Study ID Numbers: E6553-W
First Posted: April 13, 2009    Key Record Dates
Results First Posted: March 24, 2016
Last Update Posted: March 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
Magnetic Resonance Imaging
Alzheimer disease
Mild cognitive impairment
Continuous arterial spin labeling
Semantic memory
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders