Alzheimer's Disease Neuroimaging Initiative Grand Opportunity

Completed

Conditions studied: Mild Cognitive Impairment, Alzheimer's Disease

In brief

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), 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). ADNI-GO seeks to define and characterize the mildest symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

Key facts

Study ID

NCT01078636

Run by

Alzheimer's Disease Cooperative Study (ADCS)

People needed

342

Starts

2010-04-01

Expected to finish

2012-10-01

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 not qualify if…

• Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure
• 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 as described in DSM-IV within the past 1 year
• Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
• History of schizophrenia
• History of alcohol or substance abuse or dependence within the past 2 years
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
• Clinically significant abnormalities in B12, or TFTs that might interfere with the study
• Residence in skilled nursing facility
• Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of warfarin (exclusionary for lumbar puncture)
• Use of investigational agents one month prior to entry and for the duration of the trial
• Participation in clinical studies involving neuropsychological measures being collected more than one time per year
• Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1
• Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of California, Irvine - BIC — Irvine, 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 — Martinez, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, 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
• Wien Center — Miami Beach, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University 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
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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