Status:
COMPLETED
ADNI: Alzheimer's Disease Neuroimaging Initiative
Lead Sponsor:
Alzheimer's Disease Cooperative Study (ADCS)
Collaborating Sponsors:
Northern California Institute of Research and Education
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-90 years
Brief Summary
The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This...
Detailed Description
This study will test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to me...
Eligibility Criteria
Inclusion
- Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
- General (applies to each category):
- Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems)
- Study partner or caregiver to accompany patient to all scheduled visits
- Fluent in English or Spanish
- Permitted medications stable for at least 4 weeks prior to screening
- Adequate visual and auditory acuity to allow neuropsychological testing
- Good general health with no additional diseases expected to interfere with the study
- Women must be two years post-menopausal or surgically sterile
- Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol
- Willing to undergo neuroimaging and provide DNA and plasma samples as specified
- Completed 6 grades of education or sufficient work history to exclude mental retardation
- Modified Hachinski score \<=4
- Geriatric Depression Scale \<6
- Specific Criteria for MCI and AD patients:
- Memory complaint by patient or study partner
- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD)
- Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD)
Exclusion
- Any significant neurologic disease other than Alzheimer's disease
- Abnormal baseline MRI
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body
- Major depression, bipolar disorder, history of schizophrenia
- History of alcohol or substance abuse or dependency within the past 2 years
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- Clinically significant laboratory abnormalities
- Residence in skilled nursing facility
- Participation in clinical studies involving neuropsychological measures being collected more than one time per year
- Specific Exclusion Criteria for MCI and AD:
- Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- Prohibited medications:
- Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.)
- Warfarin (Coumadin)
- Investigational agents
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT00106899
Start Date
July 1 2005
End Date
June 1 2011
Last Update
September 16 2014
Active Locations (59)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
3
Sun Health / Arizona Consortium
Sun City, Arizona, United States, 85351
4
University of California, Irvine
Irvine, California, United States, 92697-4285