NCT00908999

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

3.4 years

First QC Date

May 22, 2009

Last Update Submit

September 27, 2011

Conditions

Keywords

anosognosia fMRI amnestic MCI Alzheimeranosognosia in AD and MCI

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

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

AgnosiaAlzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

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

Locations