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.
This project continues the work from ADNI1, the goal of which is to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessments can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The goal of the study is to determine relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the stage of the AD spectrum that precedes MCI, the mildest symptomatic phase of AD, referred to here as EMCI. The ADNI-GO model posits that AD begins with amyloid β (Aβ) deposition in the cortex, which leads to synaptic dysfunction, neurodegeneration, and cognitive/ functional decline. Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (F-AV-45) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.) All participants from ADNI1 who are in the normal and MCI stages will continue to be followed in ADNI-GO. The next step is to scan and analyze the brains of people with EMCI; 200 EMCI participants will be enrolled to narrow the gap between cognitively normal (CN) and "late MCI (LMCI)" participants currently enrolled in ADNI. The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials of treatments to slow disease progression, ultimately contributing to the prevention of AD.
Study Type
OBSERVATIONAL
Enrollment
342
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Rate of Decline as measured by: Cognitive tests, Activities of Daily Living, and CDR Sum of Boxes
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
Rate of conversion will be evaluated among all four groups
Time frame: at screening , baseline, 6 (EMCI only) and 12 months
Rate of volume change of whole brain, hippocampus, and other structural MRI measures
Time frame: at screening and 3, 6, and 12 months (EMCI); at baseline and 12 months (follow-up patients)
Rates of change on each specified biochemical biomarker
Time frame: at baseline, 6 (EMCI only) and 12 months
Rates of change of glucose metabolism (FDG-PET)
Time frame: at baseline
Extent of amyloid deposition as measured by 18F-AV-45
Time frame: at baseline
Group differences for each imaging and biomarker measurement
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
Correlations among biomarkers and biomarker change
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
Subgroups analyses: APOE genotype, low CSF Aβ42, positive amyloid imaging with 18F-AV-45
Time frame: at baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 45 more locations