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Alzheimer's DiseaseNCT00106899

ADNI: Alzheimer's Disease Neuroimaging Initiative

An observational study of Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and Lumbar Puncture (LP)
Type of treatment
Surgery or procedure
How many people
818 participants
Where
59 sitesin 2 countries
Study dates
Jul 2005to Jun 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: community sample

Who may be able to join

  • Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
  • 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
Show all 19Show fewer
  • 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
  • Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD)
  • Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD)

Who cannot join

  • 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
Show all 15Show fewer
  • Clinically significant laboratory abnormalities
  • Residence in skilled nursing facility
  • Participation in clinical studies involving neuropsychological measures being collected more than one time per year
  • Specific Exclusion Criteria for MCI and AD:
  • 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

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States54 sites

  • Albany Medical College

    Albany, New York, 12208

  • Dent Neurological Institute

    Amherst, New York, 14266

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21287-7218

  • University of Alabama

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University Schools of Medicine and Public Health

    Boston, Massachusetts, 02118

  • Northwestern University

    Chicago, Illinois, 60611

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

    Chicago, Illinois, 60612

  • Case Western Reserve University

    Cleveland, Ohio, 44120

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Olin Neuropsychiatry Research Center

    Hartford, Connecticut, 06106

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202-5120

  • University of California, Irvine

    Irvine, California, 92697-4285

  • University of California, Irvine - Brain Imaging Center

    Irvine, California, 92697

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of California, San Diego

    La Jolla, California, 92037

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Southern California

    Los Angeles, California, 90033

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53706

  • Wein Center

    Miami, Florida, 33140

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York University

    New York, New York, 10016

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University

    New York, New York, 11032

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Dent Neurological Institute

    Orchard Park, New York, 14127

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55901-0144

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • University of California, Davis

    Sacramento, California, 95817

  • University of California, San Francisco

    San Francisco, California, 94115

  • Washington University

    St Louis, Missouri, 63108

  • Stanford University

    Stanford, California, 94304

  • Sun Health / Arizona Consortium

    Sun City, Arizona, 85351

  • Neurological Care of CNY

    Syracuse, New York, 13210

  • Byrd Alzheimer's Institute

    Tampa, Florida, 33647

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Howard University

    Washington D.C., District of Columbia, 20060

  • Premiere Neurological Group

    West Palm Beach, Florida, 33407

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

  • Parkwood Hospital

    London, Ontario

  • Saint Joseph's Hospital

    London, Ontario

  • Jewish Hospital Memory Clinic, Quebec

    Montreal, Quebec, H3T 1E2

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

    Toronto, Ontario

  • University of British Columbia

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: Alzheimer's Disease Neuroimaging Initiative

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.

Read the detailed description

This study will test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The information obtained by studying changes in the brain images of MCI and AD patients and healthy individuals, as well as other assessment tools, will be used to determine the best methods for measuring treatment effects in patients with MCI and AD.

Approximately 800 participants, ranging in age from 55 to 90, will be recruited for the study: 400 patients with MCI, 200 with early AD, and 200 normal controls. Patients with MCI and normal controls will be followed for 3 years, and those with AD will be followed for 2 years. At 6-month intervals, all participants will be seen in person or contacted by telephone. All participants will undergo repeated scanning and blood and urine biomarkers will be collected at the time of each scan. All patients will be asked if they are willing to undergo lumbar puncture at baseline and year one, with the goal of a minimum of 20% and as many as 50% of each group providing CSF (cerebrospinal fluid) samples for analysis and storage for future analyses.

NOTE: Beginning in Spring 2007 a subset of the ADNI participants will be offered the opportunity to participate in a supplemental study. The PIB (Pittsburgh Compound B) study provides imaging of amyloid plaque burden. PIB PET scans will be conducted in 24 control, 48 MCI, and 24 AD participants at approximately 16 ADNI PET sites. For entering participants with no previous PET FDG scans, controls and MCI participants will be scanned with PIB at entry (baseline), 12, 24, and 36 months, and AD participants will be scanned with PIB at entry (baseline), 12, and 24 months. For participants who have undergone previous (baseline and 6 month) PET FDG scans, controls and MCI participants will be scanned with PIB at 12, 24, and 36 months, and AD participants will be scanned with PIB at 12 and 24 months.

Being tested
Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), Lumbar Puncture (LP)
Keywords
neuroimaging, brain metabolism, biomarkers, cognition disorder, Mild Cognitive Impairment
Medical subject headings
Alzheimer Disease, Cognition Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    MRI scans

  • Positron Emission Tomography (PET)Procedure or surgery

    PET scans

  • Lumbar Puncture (LP)Procedure or surgery

    Also called spinal tap

    collection of cerebrospinal fluid

Study groups in NCT00106899
Study groupRoleWhat they receive
1Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)
2Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)
3Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Procedure: Lumbar Puncture (LP)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
818 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106899
Sponsor's protocol ID
IA0068
Other IDs
1RC2AG036535, 1U01AG024904
Status last verified
Sep 2014
First submitted
31 Mar 2005
Last updated
16 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12714109

  • 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.

    PubMed 14732621

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

    PubMed 12904814

  • Mukesha D, Firat H, Sacco G. Integrating large-scale serum metabolomics and APOE epsilon4 genotype status for the non-invasive detection of Alzheimer's disease in the ADNI cohort. medRxiv [Preprint]. 2026 Jan 16:2025.12.29.25343146. doi: 10.64898/2025.12.29.25343146.

    PubMed 41646720

  • 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; Alzheimer's Disease Neuroimaging Initiative. Early axonal degeneration linked to clinical decline in Alzheimer's disease progression revealed with diffusion MRI. J Clin Invest. 2025 Nov 27;136(3):e196638. doi: 10.1172/JCI196638. eCollection 2026 Feb 2.

    PubMed 41307953

  • 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.

    PubMed 39948600

  • 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.

    PubMed 39324520

  • Xu B, Ling Y, Liu L, Liu Y, Lin Y, Lyu J, Zhang Y. Potential prognostic value of CSF-targeted proteomics across the Alzheimer's disease continuum. BMC Geriatr. 2024 Jun 6;24(1):501. doi: 10.1186/s12877-024-05104-z.

    PubMed 38844858

  • 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.

    PubMed 37117993

  • 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.

    PubMed 37081528

  • 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.

    PubMed 36793451

  • 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.

    PubMed 36253968

  • 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.

    PubMed 32785820

  • 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.

    PubMed 22963265

  • 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.

    PubMed 22503160

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106899, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.

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