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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 29, 2011
September 1, 2011
3.4 years
May 22, 2009
September 27, 2011
Conditions
Keywords
Study Arms (3)
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 Criteria
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).
You may qualify if:
- Amnestic MCI:
- Observation of memory decline by informant.
- Mini Mental Status Exam (MMSE) score between 24 and 30.
- Objective memory impairment on neuropsychological tests.
- Intact functional abilities, and 4) no diagnosis of dementia.
- AD:
- A diagnosis of probable AD according with the NINDS-ADRDA and DSM-IV diagnostic criteria.
- MMSE score between 16 and 27. All AD patients will have capacity to provide informed consent as judged by the referring physician.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William S Middleton VA Hospital GRECC
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 27, 2009
Study Start
April 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 29, 2011
Record last verified: 2011-09