ClinicalTrials.Veeva

Menu

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

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Alzheimer's Disease
Mild Cognitive Impairment
Anosognosia

Study type

Observational

Funder types

Other

Identifiers

NCT00908999
HSC-2008-0090

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

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.
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.
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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems