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

This study is currently recruiting participants.
Verified December 2013 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00880555
First received: April 10, 2009
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

Alzheimer's disease 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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in financial capacity (measured with Financial Capacity Instrument) [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

N/A- no biospecimens


Estimated Enrollment: 160
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
Group 2
Elderly controls without memory impairment
Group 3
Patients with mild Alzheimer disease (but preserved routine ADLs)

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880555

Contacts
Contact: David G Clark, MD (205) 996-6050 dgclark@uab.edu
Contact: Kathryn L Burgio, PhD MA BA (205) 933-8101 ext 7307 kathryn.burgio@va.gov

Locations
United States, Alabama
VA Medical Center, Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: David G Clark, MD    205-996-6050    dgclark@uab.edu   
Principal Investigator: David G Clark, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: David G Clark, MD VA Medical Center, Birmingham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00880555     History of Changes
Other Study ID Numbers: E6553-W
Study First Received: April 10, 2009
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Magnetic Resonance Imaging
Alzheimer disease
Mild cognitive impairment
Continuous arterial spin labeling
Semantic memory

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014