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

NCT ID: NCT00908999

Last Updated: 2011-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-09-30

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.

Conditions

Anosognosia; Alzheimer's Disease; Mild Cognitive Impairment

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

William S Middleton VA Hospital GRECC

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

HSC-2008-0090

Identifier Type: -

Identifier Source: org_study_id