Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)
- Conditions
- Mild Cognitive Impairment (MCI)Alzheimer's Disease (AD)
- Registration Number
- NCT02854033
- Lead Sponsor
- University of Southern California
- Brief Summary
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.
- Detailed Description
The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios.
This is multi-center, a non-randomized, natural history, non-treatment study. 1,070-2,000 total participants will be enrolled across three cohorts: cognitively normal\* (CN), mild cognitive impairment (MCI) and mild Alzheimer's Disease (AD) dementia. Participants between the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts.
Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
\*currently recruiting non-Caucasian participants only for the cognitively normal cohort.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) 5 years The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained.
Rate of change in cognition as measured by the Logical Memory Test I and II 5 years Rate of change in cognition as measured by the Mini-Mental State Examinations (MMSE) 5 years The MMSE scale evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons.
- Secondary Outcome Measures
Name Time Method Rate of change in cognition as measured by the American National Adult Reading Test (ANART) 5 years The ANART estimates premorbid verbal intelligence (VIQ) in patients with dementia.
Rate of change in cognition as measured by the Cogstate Brief Battery (CBB) 5 years The Cogstate Brief battery (CBB) is a brief (10-15 minute) computerized cognitive battery developed by Cogstate (Cogstate Ltd. New Haven, CT, USA) that measures attention, speed of information processing, working memory and learning.
Rate of change in cognition as measured by the Rey Auditory Verbal Learning Test 5 years The AVLT is a list-learning task, which assesses multiple cognitive parameters associated with learning and memory.
Rate of change in cognition as measured by the Trail Making Test: A and B 5 years Change in tau deposition as measured by 18F-AV-1451 5 years Change in amyloid deposition as measured by Florbetapir 5 years Change in amyloid deposition as measured by Florbetaben 5 years Rate of change in cognition as measured by the Montreal Cognitive Assessment (MoCA) 5 years The Montreal Cognitive Assessment test (MoCA) is a cognitive assessment designed to detect participants at the MCI stage of cognitive dysfunction.
Rate of conversion to MCI or dementia due to AD 5 years Rates of change of glucose metabolism (FDG-PET) 5 years Change in Cerebral Spinal Fluid (CSF) Tau Biomarkers 5 years Change in brain structure using magnetic resonance imaging (MRI) 5 years
Trial Locations
- Locations (59)
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Barrow Neurological 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, San Diego
🇺🇸La Jolla, California, United States
Long Beach VA Neuropsychiatric Research Program
🇺🇸Long Beach, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
VA Palo Alto HSC / Stanford School of Medicine
🇺🇸Palo Alto, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of California, Davis
🇺🇸Walnut Creek, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Mayo Clinic, Jacksonville
🇺🇸Jacksonville, Florida, United States
Wien Center for Clinical Research
🇺🇸Miami Beach, Florida, United States
University of South Florida - Health Byrd Alzheimer Institute
🇺🇸Tampa, 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 Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas
🇺🇸Fairway, 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
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Michigan, Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Washington University, St. Louis
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Albany Medical College
🇺🇸Albany, New York, United States
Dent Neurologic Institute
🇺🇸Buffalo, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
Nathan Kline Institute for Psychiatric Research
🇺🇸Orangeburg, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Case Western Reserve University
🇺🇸Beachwood, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Butler Hospital Memory and Aging Program
🇺🇸Providence, Rhode Island, United States
Ralph H. Johnson VA Health Care System
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas, Southwestern MC at Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist
🇺🇸Houston, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of British Columbia, Clinic for AD & Related
🇨🇦Vancouver, British Columbia, Canada
Parkwood Institute
🇨🇦London, Ontario, Canada
St. Joseph's Health Center - Cognitive Neurology
🇨🇦London, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital Memory Clinic
🇨🇦Montreal, Quebec, Canada