Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol (ADNI3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02854033|
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : November 6, 2020
|Condition or disease|
|Mild Cognitive Impairment (MCI) Alzheimer's Disease (AD)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Cognitively Normal (CN)
135-500 newly enrolled participants with no apparent memory problems, and 295-300 cognitively normal participants followed from the ADNI2 study.
Currently recruiting non-Caucasian participants only for the normal cognition group.
Mild Cognitive Impairment (MCI)
150 - 515 newly enrolled participants with mild cognitive impairment (MCI), and 275-320 MCI participants followed from the ADNI2 study.
Mild Alzheimer's Disease (AD) dementia
85 - 185 newly enrolled participants with mild Alzheimer's disease (AD) dementia, and 130 - 150 mild AD participants followed from the ADNI2 study.
- Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) [ Time Frame: 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 [ Time Frame: 5 years ]
- Rate of change in cognition as measured by the Mini-Mental State Examinations (MMSE) [ Time Frame: 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.
- Rate of change in cognition as measured by the Cogstate Brief Battery (CBB) [ Time Frame: 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 American National Adult Reading Test (ANART) [ Time Frame: 5 years ]The ANART estimates premorbid verbal intelligence (VIQ) in patients with dementia.
- Rate of change in cognition as measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: 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 change in cognition as measured by the Rey Auditory Verbal Learning Test [ Time Frame: 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 [ Time Frame: 5 years ]
- Change in tau deposition as measured by 18F-AV-1451 [ Time Frame: 5 years ]
- Change in amyloid deposition as measured by Florbetapir [ Time Frame: 5 years ]
- Change in amyloid deposition as measured by Florbetaben [ Time Frame: 5 years ]
- Rate of conversion to MCI or dementia due to AD [ Time Frame: 5 years ]
- Rates of change of glucose metabolism (FDG-PET) [ Time Frame: 5 years ]
- Change in Cerebral Spinal Fluid (CSF) Tau Biomarkers [ Time Frame: 5 years ]
- Change in brain structure using magnetic resonance imaging (MRI) [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854033
|Contact: ADNI Central Phone Number||888-2-ADNI-95 (888-223-6495)||firstname.lastname@example.org|
|Study Director:||Michael W. Weiner, MD||University of California, San Francisco|
|Principal Investigator:||Paul Aisen, MD||USC Alzheimer's Therapeutic Research Institute (ATRI)|
|Principal Investigator:||Ronald Peterson, MD, PHD||Mayo Clinic|