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

Mild Cognitive Impairment Clinical Trial

Official title:

FMRI of Anosognosia in Amnestic MCI and AD: Focus on Cortical Midline Structures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908999
• Other study ID #: HSC-2008-0090
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: September 27, 2011
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Anosognosia
• Cognition Disorders
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	William S Middleton VA Hospital GRECC	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States,