ADNI: Alzheimer's Disease Neuroimaging Initiative

NCT00106899 | Completed DMC

• 3 other identifiers: IA00681RC2AG0365351U01AG024904
• Study Type: observational
• Target: 818
• Locations: 2 countries
• Sites: 59

Brief Summary

The purpose of this study is 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). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.

Conditions

Alzheimer's Disease

Keywords

neuroimaging; brain metabolism; biomarkers; cognition disorder; Mild Cognitive Impairment

Study Arms (3)

1

Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)

2

Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)

3

Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

MRI scans

1; 2; 3

Positron Emission Tomography (PET) PROCEDURE

PET scans

1; 2; 3

Lumbar Puncture (LP) PROCEDURE

collection of cerebrospinal fluid

Also known as: spinal tap

1; 2; 3

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• General (applies to each category):
• Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems)
• Study partner or caregiver to accompany patient to all scheduled visits
• Fluent in English or Spanish
• Permitted medications stable for at least 4 weeks prior to screening
• Adequate visual and auditory acuity to allow neuropsychological testing
• Good general health with no additional diseases expected to interfere with the study
• Women must be two years post-menopausal or surgically sterile
• Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol
• Willing to undergo neuroimaging and provide DNA and plasma samples as specified
• Completed 6 grades of education or sufficient work history to exclude mental retardation
• Modified Hachinski score \<=4
• Geriatric Depression Scale \<6
• Specific Criteria for MCI and AD patients:
• Memory complaint by patient or study partner

You may not qualify if:

• Any significant neurologic disease other than Alzheimer's disease
• Abnormal baseline MRI
• Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body
• Major depression, bipolar disorder, history of schizophrenia
• History of alcohol or substance abuse or dependency within the past 2 years
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
• Clinically significant laboratory abnormalities
• Residence in skilled nursing facility
• Participation in clinical studies involving neuropsychological measures being collected more than one time per year
• Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
• Prohibited medications:
• Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.)
• Warfarin (Coumadin)
• Investigational agents

Sponsors & Collaborators

• Alzheimer's Disease Cooperative Study (ADCS): lead
• Northern California Institute of Research and Education: collaborator
• National Institute on Aging (NIA): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Foundation for the National Institutes of Health: collaborator
• Alzheimer's Drug Discovery Foundation: collaborator
• Alzheimer's Association: collaborator

Study Sites (59)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Sun Health / Arizona Consortium

Sun City, Arizona, 85351, United States

Location

University of California, Irvine

Irvine, California, 92697-4285, United States

Location

University of California, Irvine - Brain Imaging Center

Irvine, California, 92697, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Wein Center

Miami, Florida, 33140, United States

Location

Byrd Alzheimer's Institute

Tampa, Florida, 33647, United States

Location

Premiere Neurological Group

West Palm Beach, Florida, 33407, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center/Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202-5120, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-7218, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University Schools of Medicine and Public Health

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55901-0144, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Dent Neurological Institute

Amherst, New York, 14266, United States

Location

New York University

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 11032, United States

Location

Dent Neurological Institute

Orchard Park, New York, 14127, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Neurological Care of CNY

Syracuse, New York, 13210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44120, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

Parkwood Hospital

London, Ontario, Canada

Location

Saint Joseph's Hospital

London, Ontario, Canada

Location

Sunnybrook and Women's College, Health Sciences Centre, University of Toronto

Toronto, Ontario, Canada

Location

Jewish Hospital Memory Clinic, Quebec

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (17)

• Frank RA, Galasko D, Hampel H, Hardy J, de Leon MJ, Mehta PD, Rogers J, Siemers E, Trojanowski JQ; National Institute on Aging Biological Markers Working Group. Biological markers for therapeutic trials in Alzheimer's disease. Proceedings of the biological markers working group; NIA initiative on neuroimaging in Alzheimer's disease. Neurobiol Aging. 2003 Jul-Aug;24(4):521-36. doi: 10.1016/s0197-4580(03)00002-2. No abstract available.

  PMID: 12714109 BACKGROUND

• Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.

  PMID: 14732621 BACKGROUND

• Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.

  PMID: 12904814 BACKGROUND

• Gong Z, Laporte JP, Guo AY, Bilgel M, Bae J, Fox NY, de Rouen A, Zhang N, Taranath A, de Cabo R, Egan JM, Ferrucci L, Bouhrara M. Early axonal degeneration linked to clinical decline in Alzheimer's disease progression revealed with diffusion MRI. J Clin Invest. 2025 Nov 27:e196638. doi: 10.1172/JCI196638. Online ahead of print.

  PMID: 41307953 DERIVED

• Yang S, Zhang X, Du X, Yan P, Zhang J, Wang W, Wang J, Zhang L, Sun H, Liu Y, Xu X, Di Y, Zhong J, Wu C, Reinhardt JD, Zheng Y, Wu T. Prediction of cognitive conversion within the Alzheimer's disease continuum using deep learning. Alzheimers Res Ther. 2025 Feb 13;17(1):41. doi: 10.1186/s13195-025-01686-x.

  PMID: 39948600 DERIVED

• Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.

  PMID: 39324520 DERIVED

• Cullen NC, Leuzy A, Palmqvist S, Janelidze S, Stomrud E, Pesini P, Sarasa L, Allue JA, Proctor NK, Zetterberg H, Dage JL, Blennow K, Mattsson-Carlgren N, Hansson O. Individualized prognosis of cognitive decline and dementia in mild cognitive impairment based on plasma biomarker combinations. Nat Aging. 2021 Jan;1(1):114-123. doi: 10.1038/s43587-020-00003-5. Epub 2020 Nov 30.

  PMID: 37117993 DERIVED

• Klingenberg M, Stark D, Eitel F, Budding C, Habes M, Ritter K; Alzheimer's Disease Neuroimaging Initiative. Higher performance for women than men in MRI-based Alzheimer's disease detection. Alzheimers Res Ther. 2023 Apr 20;15(1):84. doi: 10.1186/s13195-023-01225-6.

  PMID: 37081528 DERIVED

• Behzad M, Zirak N, Madani GH, Baidoo L, Rezaei A, Karbasi S, Sadeghi M, Shafie M, Mayeli M, Alzheimer's Disease Neuroimaging Initiative. CSF-Targeted Proteomics Indicate Amyloid-Beta Ratios in Patients with Alzheimer's Dementia Spectrum. Int J Alzheimers Dis. 2023 Feb 6;2023:5336273. doi: 10.1155/2023/5336273. eCollection 2023.

  PMID: 36793451 DERIVED

• Rouch L, Virecoulon Giudici K, Cantet C, Guyonnet S, Delrieu J, Legrand P, Catheline D, Andrieu S, Weiner M, de Souto Barreto P, Vellas B; Alzheimer's Disease Neuroimaging Initiative. Associations of erythrocyte omega-3 fatty acids with cognition, brain imaging and biomarkers in the Alzheimer's disease neuroimaging initiative: cross-sectional and longitudinal retrospective analyses. Am J Clin Nutr. 2022 Dec 19;116(6):1492-1506. doi: 10.1093/ajcn/nqac236.

  PMID: 36253968 DERIVED

• Xu G, Zheng S, Zhu Z, Yu X, Jiang J, Jiang J, Chu Z; Alzheimer's Disease Neuroimaging Initiative. Association of tau accumulation and atrophy in mild cognitive impairment: a longitudinal study. Ann Nucl Med. 2020 Nov;34(11):815-823. doi: 10.1007/s12149-020-01506-2. Epub 2020 Aug 12.

  PMID: 32785820 DERIVED

• Kennedy RE, Schneider LS, Cutter GR; Alzheimer's Disease Neuroimaging Initiative. Biomarker positive and negative subjects in the ADNI cohort: clinical characterization. Curr Alzheimer Res. 2012 Dec;9(10):1135-41. doi: 10.2174/156720512804142976.

  PMID: 22963265 DERIVED

• Grill JD, Di L, Lu PH, Lee C, Ringman J, Apostolova LG, Chow N, Kohannim O, Cummings JL, Thompson PM, Elashoff D; Alzheimer's Disease Neuroimaging Initiative. Estimating sample sizes for predementia Alzheimer's trials based on the Alzheimer's Disease Neuroimaging Initiative. Neurobiol Aging. 2013 Jan;34(1):62-72. doi: 10.1016/j.neurobiolaging.2012.03.006. Epub 2012 Apr 13.

  PMID: 22503160 DERIVED

• Schrag A, Schott JM; Alzheimer's Disease Neuroimaging Initiative. What is the clinically relevant change on the ADAS-Cog? J Neurol Neurosurg Psychiatry. 2012 Feb;83(2):171-3. doi: 10.1136/jnnp-2011-300881. Epub 2011 Oct 21.

  PMID: 22019547 DERIVED

• Samtani MN, Farnum M, Lobanov V, Yang E, Raghavan N, Dibernardo A, Narayan V; Alzheimer's Disease Neuroimaging Initiative. An improved model for disease progression in patients from the Alzheimer's disease neuroimaging initiative. J Clin Pharmacol. 2012 May;52(5):629-44. doi: 10.1177/0091270011405497. Epub 2011 Jun 9.

  PMID: 21659625 DERIVED

• Schneider LS, Insel PS, Weiner MW; Alzheimer's Disease Neuroimaging Initiative. Treatment with cholinesterase inhibitors and memantine of patients in the Alzheimer's Disease Neuroimaging Initiative. Arch Neurol. 2011 Jan;68(1):58-66. doi: 10.1001/archneurol.2010.343.

  PMID: 21220675 DERIVED

• Schneider LS, Kennedy RE, Cutter GR; Alzheimer's Disease Neuroimaging Initiative. Requiring an amyloid-beta1-42 biomarker for prodromal Alzheimer's disease or mild cognitive impairment does not lead to more efficient clinical trials. Alzheimers Dement. 2010 Sep;6(5):367-77. doi: 10.1016/j.jalz.2010.07.004.

  PMID: 20813339 DERIVED

Related Links

• Alzheimer's Disease Neuroimaging Initiative--Additional Information
• Laboratory of Neuro Imaging: Alzheimer's Disease Neuroimaging Initiative
• Alzheimer's Disease Cooperative Study
• ADEAR Center

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, cerebrospinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Cognition Disorders; Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy; Spinal Puncture

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Michael W. Weiner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ronald Petersen, MD, PhD

  Mayo Clinic - Rochester, Minnesota

  PRINCIPAL INVESTIGATOR

• Paul Aisen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2005
• First Posted: April 1, 2005
• Study Start: July 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (54); CA (5)