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About
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.
Full 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.
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Inclusion and exclusion criteria
Inclusion Criteria (all CN participants):
Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age
Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
Clinical Dementia Rating = 0. Memory Box score must be 0
Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
Stability of Permitted Medications for at least 4 weeks:
Inclusion Criteria (all MCI participants):
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.
Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
a. < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6 for 0-7 years of education
Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the Screening Visit
Stability of Permitted Medications for at least 4 weeks:
Inclusion Criteria (all AD participants):
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n.
Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
Mini-Mental State Exam score between 20 and 26 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
Clinical Dementia Rating = 0.5 or 1.0
NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD
Stability of Permitted Medications for at least 4 weeks:
Inclusion Criteria Specific to Newly Enrolled Participants
The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:
Exclusion Criteria (all CN participants):
Exclusion Criteria (all MCI participants):
Exclusion Criteria (all AD participants):
Exclusion Criteria (all participants):
The following additional exclusion criteria apply to all diagnostic categories:
Exclusion Criteria Specific to AV-1451 PET:
The following criteria are exclusionary only for the AV-1451 scanning portion of the study:
2,000 participants in 3 patient groups
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ADNI Study Central Phone Number
Data sourced from clinicaltrials.gov
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