ADNI: Alzheimer's Disease Neuroimaging Initiative

September 15, 2014 updated by: Alzheimer's Disease Cooperative Study (ADCS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

818

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
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 Names:
  • spinal tap
2
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 Names:
  • spinal tap
3
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 Names:
  • spinal tap

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alzheimer's Disease Cooperative Study (ADCS)

Collaborators

National Institute on Aging (NIA)
Northern California Institute of Research and Education
Alzheimer's Association
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Alzheimer's Drug Discovery Foundation
Foundation for the National Institutes of Health

Investigators

  • Principal Investigator: Ronald Petersen, MD, PhD, Mayo Clinic - Rochester, Minnesota
  • Principal Investigator: Paul Aisen, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

March 31, 2005

First Submitted That Met QC Criteria

March 31, 2005

First Posted (ESTIMATE)

April 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0068
  • 1RC2AG036535 (U.S. NIH Grant/Contract)
  • 1U01AG024904 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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