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

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

Sponsors

Lead Sponsor: University of Wisconsin, Madison

Source University of Wisconsin, Madison
Brief 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.

Overall Status Completed
Start Date April 2008
Completion Date September 2011
Primary Completion Date September 2011
Study Type Observational
Enrollment 60
Condition
Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 60 Years

Maximum Age: 90 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: William S Middleton VA Hospital GRECC
Location Countries

United States

Verification Date

September 2011

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Controls

Description: 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.

Label: amnestic Mild Cognitive Impairment

Description: 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.

Label: Alzheimer's disease

Description: 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.

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov