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ADNI: Alzheimer's Disease Neuroimaging Initiative

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ClinicalTrials.gov Identifier: NCT00106899
Recruitment Status : Completed
First Posted : April 1, 2005
Last Update Posted : September 16, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Alzheimer's Disease Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET) Procedure: Lumbar Puncture (LP)

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.

Study Design

Study Type : Observational
Actual Enrollment : 818 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alzheimer's Disease Neuroimaging Initiative
Study Start Date : July 2005
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap
Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap
Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap

Outcome Measures

Biospecimen Retention:   Samples With DNA
blood, urine, cerebrospinal fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample

Inclusion Criteria:

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
  • 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)

Exclusion Criteria:

  • 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

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00106899

  Hide Study Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Sun Health / Arizona Consortium
Sun City, Arizona, United States, 85351
United States, California
University of California, Irvine
Irvine, California, United States, 92697-4285
University of California, Irvine - Brain Imaging Center
Irvine, California, United States, 92697
University of California, San Diego
La Jolla, California, United States, 92037
University of Southern California
Los Angeles, California, United States, 90033
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94115
Stanford University
Stanford, California, United States, 94304
United States, Connecticut
Olin Neuropsychiatry Research Center
Hartford, Connecticut, United States, 06106
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
Howard University
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
Wein Center
Miami, Florida, United States, 33140
Byrd Alzheimer's Institute
Tampa, Florida, United States, 33647
Premiere Neurological Group
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center/Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202-5120
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-7218
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University Schools of Medicine and Public Health
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55901-0144
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Dent Neurological Institute
Amherst, New York, United States, 14266
New York University
New York, New York, United States, 10016
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 11032
Dent Neurological Institute
Orchard Park, New York, United States, 14127
University of Rochester Medical Center
Rochester, New York, United States, 14620
Neurological Care of CNY
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Wake Forest University
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44120
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Parkwood Hospital
London, Ontario, Canada
Saint Joseph's Hospital
London, Ontario, Canada
Sunnybrook and Women's College, Health Sciences Centre, University of Toronto
Toronto, Ontario, Canada
Canada, Quebec
Jewish Hospital Memory Clinic, Quebec
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
Northern California Institute of Research and Education
National Institute on Aging (NIA)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Foundation for the National Institutes of Health
Alzheimer’s Drug Discovery Foundation
Alzheimer's Association
Principal Investigator: 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
More Information

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

Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00106899     History of Changes
Other Study ID Numbers: IA0068
1RC2AG036535 ( U.S. NIH Grant/Contract )
1U01AG024904 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2005    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by Alzheimer's Disease Cooperative Study (ADCS):
brain metabolism
cognition disorder
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders