ADNI: Alzheimer's Disease Neuroimaging Initiative

Completed

Conditions studied: Alzheimer's Disease

In brief

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 information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.

Key facts

Study ID

NCT00106899

Run by

Alzheimer's Disease Cooperative Study (ADCS)

People needed

818

Starts

2005-07-01

Expected to finish

2011-06-01

Last updated by the study team

2014-09-16

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Sun Health / Arizona Consortium — Sun City, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of California, Irvine - Brain Imaging Center — Irvine, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Olin Neuropsychiatry Research Center — Hartford, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Howard University — Washington D.C., District of Columbia, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Wein Center — Miami, Florida, United States
• Byrd Alzheimer's Institute — Tampa, Florida, United States
• Premiere Neurological Group — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center/Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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