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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.

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.

Status: Completed (N/A). Started on July 1st, 2005.

Enrollment: 800 subjects

Study Type: Observational

Study Design:

  • Observational Model: Case Control
  • Time Perspective: Prospective

Conditions:

Interventions:

  • Procedure: Magnetic Resonance Imaging (MRI)
  • Procedure: Positron Emission Tomography (PET)
  • Procedure: Lumbar Puncture (LP) (spinal tap)

Eligibility

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

Gender

Both

Mininum Age

55 Years

Maximum Age

90 Years

Healthy Volunteers

Accepts Healthy Volunteers

Resources

Source: Alzheimer's Disease Cooperative Study (ADCS)

Authority: United States: Federal Government

Locations

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

Officials

  • Michael W. Weiner, MD (Principal Investigator, University of California, San Francisco)

  • Ronald Petersen, MD, PhD (Principal Investigator, Mayo Clinic, Rochester, Minnesota)

  • Paul Aisen, MD (Principal Investigator, University of California, San Diego)

Sponsors

  • Alzheimer's Disease Cooperative Study (ADCS) (Lead Sponsor)

  • Northern California Institute for Research and Education (NCIRE) (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)

References

  • 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. Review. No abstract available.
    PMID: 12714109.
    Check for Full Text

  • 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.
    PMID: 14732621.
    Check for Full Text

  • Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. Review. No abstract available.
    PMID: 12904814.
    Check for Full Text

Links

Date Verified
September 1st, 2011
First Received
September 7th, 2011
Last Changed
September 7th, 2011

Information obtained from ClinicalTrials.gov on September 07, 2011. Link to the current ClinicalTrials.gov record.

All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.

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