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

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00880555
First received: April 10, 2009
Last updated: February 24, 2016
Last verified: February 2016
  Purpose
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
Alzheimer Disease
Dementia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Semantic Memory, Financial Capacity and Brain Perfusion in MCI

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • FCI Score at Follow-up [ Time Frame: Year 1, Year 2, Year 3 ] [ Designated as safety issue: No ]
    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

Enrollment: 78
Study Start Date: April 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.
  Eligibility

Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT00880555

Locations
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
Principal Investigator: David G Clark, MD Birmingham VA Medical Center, Birmingham, AL
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00880555     History of Changes
Other Study ID Numbers: E6553-W 
Study First Received: April 10, 2009
Results First Received: November 10, 2015
Last Updated: February 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
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:
Alzheimer Disease
Dementia
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 27, 2016