Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol (ADNI3)

• ClinicalTrials.gov Identifier: NCT02854033
• Recruitment Status: Recruiting
• First Posted: August 3, 2016
• Last Update Posted: January 31, 2023
• Sponsor: University of Southern California
• Collaborators: Northern California Institute of Research and Education; National Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute
• Information provided by (Responsible Party): Paul Aisen, University of Southern California

Study Description

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.

Condition or disease
Mild Cognitive Impairment (MCI); Alzheimer's Disease (AD)

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
• Study Start Date: October 2016
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Rate of change in cognition as measured by the Logical Memory Test I and II [ Time Frame: 5 years ]
3. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. Rate of change in cognition as measured by the Trail Making Test: A and B [ Time Frame: 5 years ]
6. Change in tau deposition as measured by 18F-AV-1451 [ Time Frame: 5 years ]
7. Change in amyloid deposition as measured by Florbetapir [ Time Frame: 5 years ]
8. Change in amyloid deposition as measured by Florbetaben [ Time Frame: 5 years ]
9. Rate of conversion to MCI or dementia due to AD [ Time Frame: 5 years ]
10. Rates of change of glucose metabolism (FDG-PET) [ Time Frame: 5 years ]
11. Change in Cerebral Spinal Fluid (CSF) Tau Biomarkers [ Time Frame: 5 years ]
12. Change in brain structure using magnetic resonance imaging (MRI) [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

blood, urine, cerebrospinal fluid

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Cognitively normal (CN), mild cognitive impairment (MCI), and mild AD dementia participants.

Criteria

Inclusion Criteria (all CN participants):

1. Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age

2. 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):

   1. 9 for 16 or more years of education
   2. 5 for 8-15 years of education
   3. 3 for 0-7 years of education
3. 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)
4. Clinical Dementia Rating = 0. Memory Box score must be 0
5. Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living

6. Stability of Permitted Medications for at least 4 weeks:

   1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
   2. Estrogen replacement therapy is permissible
   3. Gingko biloba is permissible, but discouraged
   4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening.

Inclusion Criteria (all MCI participants):

1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.

2. 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

3. 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)
4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
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

6. Stability of Permitted Medications for at least 4 weeks:

   1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
   2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
   3. Estrogen replacement therapy is permissible
   4. Gingko biloba is permissible, but discouraged
   5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening.

Inclusion Criteria (all AD participants):

1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n.

2. 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):

   1. ≤ 8 for 16 or more years of education
   2. ≤ 4 for 8-15 years of education
   3. ≤ 2 for 0-7 years of education
3. 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)
4. Clinical Dementia Rating = 0.5 or 1.0
5. NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD

6. Stability of Permitted Medications for at least 4 weeks:

   1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
   2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
   3. Estrogen replacement therapy is permissible
   4. Gingko biloba is permissible, but discouraged
   5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening.

Inclusion Criteria Specific to Newly Enrolled Participants

1. Geriatric Depression Scale score less than 6.
2. Age between 55-90 years (inclusive).
3. Study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
4. Visual and auditory acuity adequate for neuropsychological testing.
5. Good general health with no diseases expected to interfere with the study.
6. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
7. Willing and able to participate in a longitudinal imaging study.
8. Modified Hachinski Ischemic Score less than or equal to 4.
9. Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
10. Must speak English or Spanish fluently.
11. Willing to undergo repeated MRIs (3Tesla) and at least two PET scans
12. Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking.
13. Agrees to collection of blood for biomarker testing.
14. Agrees to at least one lumbar puncture for the collection of CSF.
15. Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants"

The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:

1. Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year.
2. Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery.

Exclusion Criteria (all CN participants):

1. Any significant neurologic 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 deficits or known structural brain abnormalities

Exclusion Criteria (all MCI participants):

1. 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 deficits or known structural brain abnormalities.

Exclusion Criteria (all AD participants):

1. Any significant neurologic disease other than 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 deficits or known structural brain abnormalities.

Exclusion Criteria (all participants):

The following additional exclusion criteria apply to all diagnostic categories:

1. Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure
2. Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body.
3. 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 that could lead to difficulty complying with the protocol.
4. Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
5. History of schizophrenia (DSM IV criteria).
6. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol.
8. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
9. Residence in a skilled nursing facility.
10. Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture).
11. Current use of any other exclusionary medications
12. Investigational agents are prohibited one month prior to entry and for the duration of the trial.
13. Participation in clinical studies involving neuropsychological measures being collected more than one time per year.

Exclusion Criteria Specific to AV-1451 PET:

The following criteria are exclusionary only for the AV-1451 scanning portion of the study:

1. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided.
2. Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.

Contacts and Locations

Contacts

Contact: ADNI Central Phone Number; 888-2-ADNI-95 (888-223-6495); adni3-participate@usc.edu

Locations

United States, Alabama

University of Alabama, Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator: David Geldmacher, MD

United States, Arizona

Banner Alzheimer's Institute; Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator: Allison Perrin, MD

Barrow Neurological Institute; Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator: Yonas Geda, MD

Banner Sun Health Research Institute; Recruiting

Sun City, Arizona, United States, 85351

Principal Investigator: Alireza Atri, MD

United States, California

University of California, Irvine; Recruiting

Irvine, California, United States, 92697

Principal Investigator: Gaby Thai, MD

University of California, San Diego; Recruiting

La Jolla, California, United States, 920371707

Principal Investigator: James Brewer, MD, PhD

Long Beach VA Neuropsychiatric Research Program; Recruiting

Long Beach, California, United States, 90822

Principal Investigator: Christopher Reist, MD

University of Southern California; Recruiting

Los Angeles, California, United States, 900335310

Principal Investigator: Lon Schneider, MD

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Principal Investigator: Maryam Beigi, MD

VA Palo Alto HSC / Stanford School of Medicine; Recruiting

Palo Alto, California, United States, 94304

Principal Investigator: Steven Chao, MD, PhD

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94158

Principal Investigator: Peter Ljubenkov, MD

University of California, Davis; Recruiting

Walnut Creek, California, United States, 945985900

Principal Investigator: John Olichney, MD

United States, Connecticut

Yale University School of Medicine; Recruiting

New Haven, Connecticut, United States, 65103330

Principal Investigator: Christopher van Dyck, MD

United States, District of Columbia

Georgetown University; Recruiting

Washington, District of Columbia, United States, 200072145

Principal Investigator: Brigid Reynolds, RN, MSN, NP

Howard University; Recruiting

Washington, District of Columbia, United States, 200600001

Principal Investigator: Thomas Obisesan, MD

United States, Florida

Mayo Clinic, Jacksonville; Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator: Neill Graff-Radford, MD

Wien Center for Clinical Research; Recruiting

Miami Beach, Florida, United States, 331402877

Principal Investigator: Duara Ranjan, MD

University of South Florida - Health Byrd Alzheimer Institute; Recruiting

Tampa, Florida, United States, 336134808

Principal Investigator: Amanda Smith, MD

United States, Georgia

Emory University; Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator: Allan Levey, MD, PhD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 606113010

Principal Investigator: Emily Rogalski, PhD

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 606123806

Principal Investigator: Raj Shah, MD

United States, Indiana

Indiana University; Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator: Martin Farlow, MD

United States, Iowa

University of Iowa; Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator: Delwyn Miller, MD

United States, Kansas

University of Kansas; Recruiting

Fairway, Kansas, United States, 66205

Principal Investigator: Jeffrey Burns, MD, MS

United States, Kentucky

University of Kentucky; Recruiting

Lexington, Kentucky, United States, 405042681

Principal Investigator: Richard King, MD

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 212242764

Principal Investigator: Marilyn Albert, PhD

United States, Massachusetts

Brigham and Women's Hospital; Recruiting

Boston, Massachusetts, United States, 21155804

Principal Investigator: Gad Marshall, MD

Boston University School of Medicine; Recruiting

Boston, Massachusetts, United States, 21182307

Principal Investigator: Michael Alosco, PhD

United States, Michigan

University of Michigan, Ann Arbor; Recruiting

Ann Arbor, Michigan, United States, 481052967

Principal Investigator: Judith Heidebrink, MD

United States, Minnesota

Mayo Clinic, Rochester; Recruiting

Rochester, Minnesota, United States, 559050001

Principal Investigator: Ronald Peterson, MD, PhD

United States, Missouri

Washington University, St. Louis; Recruiting

Saint Louis, Missouri, United States, 631082215

Principal Investigator: Justin Long, MD

United States, Nevada

Cleveland Clinic Lou Ruvo Center for Brain Health; Recruiting

Las Vegas, Nevada, United States, 891060100

Principal Investigator: Dylan Wint, MD

United States, New York

Albany Medical College; Recruiting

Albany, New York, United States, 12208

Principal Investigator: David Hart, MD

Dent Neurologic Institute; Recruiting

Buffalo, New York, United States, 142261727

Principal Investigator: Horacio Capote, MD

New York University Medical Center; Recruiting

New York, New York, United States, 100166055

Principal Investigator: Martin Sadowski, MD, PhD

Mount Sinai School of Medicine; Recruiting

New York, New York, United States, 100296552

Principal Investigator: Hillel Grossman, MD

Columbia University; Recruiting

New York, New York, United States, 10032

Principal Investigator: Yaakov Stern, PhD

Nathan Kline Institute for Psychiatric Research; Recruiting

Orangeburg, New York, United States, 109621159

Principal Investigator: Nunzio Pomara, MD

University of Rochester; Recruiting

Rochester, New York, United States, 14620

Principal Investigator: Anton Portseinsson, MD

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator: Murali Doraiswamy, MBBS

Wake Forest University Health Sciences; Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator: Jeff Williamson, MD

United States, Ohio

Case Western Reserve University; Recruiting

Beachwood, Ohio, United States, 441224312

Principal Investigator: Alan Lerner, MD

Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Douglas Scharre, MD

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 972393011

Principal Investigator: Lisa Silbert, MD, MCR

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: David Wolk, MD

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Sub-Investigator: Oscar Lopez, MD

United States, Rhode Island

Rhode Island Hospital; Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator: Chuang-Kuo Wu, MD

Butler Hospital Memory and Aging Program; Recruiting

Providence, Rhode Island, United States, 02906

Principal Investigator: Meghan Riddle, MD

United States, South Carolina

Roper St. Francis Hospital; Recruiting

Charleston, South Carolina, United States, 29401

Principal Investigator: Olga Brawman-Minzter, MD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37212

Principal Investigator: Paul Newhouse, MD

United States, Texas

University of Texas, Southwestern MC at Dallas; Recruiting

Dallas, Texas, United States, 75390

Principal Investigator: Trung Nguyen, MD

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Valory Pavlik, PhD

Houston Methodist; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Joseph Masdeu, MD, PhD

United States, Wisconsin

University of Wisconsin; Recruiting

Madison, Wisconsin, United States, 537920001

Principal Investigator: Sterling Johnson, PhD

Canada, British Columbia

University of British Columbia, Clinic for AD & Related; Recruiting

Vancouver, British Columbia, Canada, V6T1Z3

Principal Investigator: Robin Hsiung, MD

Canada, Ontario

Parkwood Institute; Recruiting

London, Ontario, Canada, N6C 0A7

Principal Investigator: Michael Borrie, MD

St. Joseph's Health Center - Cognitive Neurology; Recruiting

London, Ontario, Canada, N6C 4R3

Principal Investigator: Elizabeth Finger, MD

Sunnybrook Health Sciences Centre; Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator: Sandra Black, MD

Canada, Quebec

Jewish General Hospital Memory Clinic; Recruiting

Montreal, Quebec, Canada, H3T 1E2

Principal Investigator: Susan Vaitekunas, MD

Sponsors and Collaborators

University of Southern California

Northern California Institute of Research and Education

National Institute on Aging (NIA)

Alzheimer's Therapeutic Research Institute

Investigators

• 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

More Information

Additional Information:

Alzheimer's Disease Neuroimaging Initiative 

Laboratory of Neuro Imaging (LONI) 

Alzheimer's Therapeutic Research Institute 

Alzheimer's Disease Education and Referral Center 

List of Alzheimer's Disease Neuroimaging Initiative Publications 

Brain Health Registry (BHR) 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rauchmann BS, Schneider-Axmann T, Perneczky R; Alzheimer's Disease Neuroimaging Initiative (ADNI). Associations of longitudinal plasma p-tau181 and NfL with tau-PET, Abeta-PET and cognition. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1289-1295. doi: 10.1136/jnnp-2020-325537. Epub 2021 Jun 29.

Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.

• Responsible Party: Paul Aisen, Director, Alzheimer's Therapeutic Research Institute, University of Southern California
• ClinicalTrials.gov Identifier: NCT02854033
• Other Study ID Numbers: ATRI-001; U01AG024904 ( U.S. NIH Grant/Contract )
• First Posted: August 3, 2016
• Last Update Posted: January 31, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Paul Aisen, University of Southern California:

amyloid; plaques; neuroimaging; biomarkers; cognition disorder; early detection; pre-dementia; dementia; Alzheimer's disease; tau

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders