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Functional Magnetic Resonance Imaging (fMRI) of Anosognosia in Amnestic Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00908999
First received: May 22, 2009
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

This is a three year fMRI study conducted at the University of Wisconsin (UW) Hospital and the William. S. Middleton VA Hospital. This study is guided by the hypothesis that reduced fMRI activity and connectivity cortical midline structures (i.e., medial frontal and ventral posterior cingulate cortex) are physiologic abnormalities that relate strongly to the compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals with amnestic MCI (aMCI) and AD. Further, the investigators hypothesize that these regional changes in fMRI activity are predictive of faster progression from aMCI to AD.


Condition
Anosognosia
Alzheimer's Disease
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: FMRI of Anosognosia in Amnestic MCI and AD: Focus on Cortical Midline Structures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 60
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
The control group have to be medically and cognitively healthy(MMSE ≥ 28; Hopkins Verbal Memory Test-Revised raw score within 1.5 SD of normative values for age and gender). These individuals are recruited from the community and all attempts will be made to match them on age and education to individuals recruited for groups of AD and aMCI.
amnestic Mild Cognitive Impairment
Participants who have expressed interest to take part in the study. A consensus from the study clinicians regarding the diagnosis will be required before a subject is enrolled. The criteria for MCI include 1) observation of memory decline by informant, 2) Mini Mental Status Exam (MMSE) score between 24 and 30, 3) objective memory impairment on neuropsychological tests, 3) intact functional abilities, and 4) no diagnosis of dementia.
Alzheimer's disease
Patients with probable Alzheimer's disease according with the NINDS-ADRDA and DSM-IV diagnostic criteria. An additional criterion is a MMSE score between 16 and 27. All AD patients must have capacity to provide informed consent as judged by the referring physician.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

MCI and AD patients are referred from memory clinics at the UW hospital, William S. Middleton Memorial Veterans Hospital (Madison, WI) and the statewide clinics offered through the Wisconsin Alzheimer's Institute (WAI).

Criteria

Inclusion Criteria:

  • Amnestic MCI:

    1. Observation of memory decline by informant.
    2. Mini Mental Status Exam (MMSE) score between 24 and 30.
    3. Objective memory impairment on neuropsychological tests.
    4. Intact functional abilities, and 4) no diagnosis of dementia.

  • AD:

    1. A diagnosis of probable AD according with the NINDS-ADRDA and DSM-IV diagnostic criteria.
    2. MMSE score between 16 and 27. All AD patients will have capacity to provide informed consent as judged by the referring physician.

Exclusion Criteria:

  • MRI incompatibility; history of neurologic disease (including prior loss of consciousness of more than 10 minutes); prior neurosurgery; or chronic medical diseases (such as poorly controlled diabetes, renal disease, or poorly controlled hypertension).
  • Excluded medications include neuroleptics, short or long acting nitrates, and Warfarin.
  • Other exclusions include: less than 10 yrs of education; Hachinski scale of 4 or more; first language other than English; poor visual or auditory acuity; pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908999

Locations
United States, Wisconsin
William S Middleton VA Hospital GRECC
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00908999     History of Changes
Other Study ID Numbers: HSC-2008-0090
Study First Received: May 22, 2009
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
anosognosia fMRI amnestic MCI Alzheimer
anosognosia in AD and MCI

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
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 May 22, 2013