Clinical Trial: ADNI: Alzheimer's Disease Neuroimaging Initiative

This study is not yet open for patient recruitment.

Sponsors and Collaborators: National Institute on Aging (NIA)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Foundation for the National Institutes of Health
Institute for the Study of Aging (ISOA)
Alzheimer's Association
Information provided by: National Institute on Aging (NIA)

Purpose

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 affects of treatments being studied.

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

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Observational
Study Design: Natural History, Longitudinal, Prospective Study

Official Title: Alzheimer's Disease Neuroimaging Initiative

Further Study Details: 

Expected Total Enrollment:  800

Study start: October 2004;  Expected completion: October 2009

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.

Eligibility

Ages Eligible for Study:  55 Years   -   90 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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
  • 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

Location Information


Alabama
      University of Alabama, Birmingham, Birmingham,  Alabama,  35233-0017,  United States
Edward Zamrini, MD,  Principal Investigator

Arizona
      Sun Health / Arizona Consortium, Sun City,  Arizona,  85351,  United States
Marwan Sabbagh, MD,  Principal Investigator

      Banner Good Samaritan Medical Center, Phoenix,  Arizona,  85006,  United States
Eric Reiman, MD,  Principal Investigator

California
      Stanford University, Stanford,  California,  94304,  United States
Jerome Yesavage, MD,  Principal Investigator

      University of California, Davis, Sacramento,  California,  95817,  United States
Charles DeCarli, MD,  Principal Investigator

      University of California, Irvine, Irvine,  California,  92697-4285,  United States
Steven Cramer, MD,  Principal Investigator

      University of California, Los Angeles, Los Angeles,  California,  90095,  United States
George Bartzokis, MD,  Principal Investigator

      University of California, San Diego, La Jolla,  California,  92037,  United States
Adam Fleisher, MD,  Principal Investigator

      University of California, San Francisco, San Francisco,  California,  94115,  United States
Howard Rosen, MD,  Principal Investigator

      University of Southern California, Los Angeles,  California,  90033,  United States
Lon Schneider, MD,  Principal Investigator

      University of California, Irvine - Brain Imaging Center, Irvine,  California,  92697,  United States
Steven G. Potkin, MD,  Principal Investigator

Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06511,  United States
Christopher van Dyck, MD,  Principal Investigator

District of Columbia
      Georgetown University, Washington,  District of Columbia,  20057,  United States
Paul Aisen, MD,  Principal Investigator

Florida
      Mayo Clinic, Jacksonville, Jacksonville,  Florida,  32224,  United States
Neill Graff-Radford, MD,  Principal Investigator

      Premiere Neurological Group, West Palm Beach,  Florida,  33407,  United States
Carl Sadowsky, MD,  Principal Investigator

      Wein Center, Miami,  Florida,  33140,  United States
Ranjan Duara, MD,  Principal Investigator

Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States
Allan Levey, MD, PhD,  Principal Investigator

Illinois
      Rush University Medical Center/Presbyterian St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Leyla deToledo-Morrell, PhD,  Principal Investigator

Indiana
      Indiana University, Indianapolis,  Indiana,  46202-5120,  United States
Martin R. Farlow, MD,  Principal Investigator

Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287-7218,  United States
Marilyn Albert, PhD,  Principal Investigator

Massachusetts
      Boston University Schools of Medicine and Public Health, Boston,  Massachusetts,  02118,  United States
Robert Green, MD, MPH,  Principal Investigator

      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
Reisa Sperling, MD, MMSc,  Principal Investigator

Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States
Judith Heidebrink, MD,  Principal Investigator

Minnesota
      Mayo Clinic, Rochester, Rochester,  Minnesota,  55901-0144,  United States
Ronald Petersen, MD, PhD,  Principal Investigator

Missouri
      Washington University, St. Louis,  Missouri,  63108,  United States
John Morris, MD,  Principal Investigator

Nevada
      University of Nevada School of Medicine, Las Vegas,  Nevada,  89102,  United States
Charles Bernick, MD,  Principal Investigator

New Hampshire
      Dartmouth Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States
Andrew Saykin, PsyD,  Principal Investigator

New York
      Columbia University, New York,  New York,  11032,  United States
Yaakov Stern, PhD,  Principal Investigator

      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
Hillel Grossman, MD,  Principal Investigator

      New York University, New York,  New York,  10016,  United States
Henry Rusinek, PhD,  Principal Investigator

      University of Rochester Medical Center, Rochester,  New York,  14620,  United States
Pierre Tariot, MD,  Principal Investigator

      Albany Medical College, Albany,  New York,  12208,  United States
Earl Zimmerman, MD,  Principal Investigator

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27705,  United States
Murali Doraiswamy, MD,  Principal Investigator

Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44120,  United States
Alexander Auchus, MD,  Principal Investigator

      Ohio State University, Columbus,  Ohio,  43210,  United States
Douglas Scharre, MD,  Principal Investigator

Oregon
      Oregon Health and Science University, Portland,  Oregon,  97239,  United States
Jeffery Kaye, MD,  Principal Investigator

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
Christopher Clark, MD,  Principal Investigator

      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
Steven T DeKosky, MD,  Principal Investigator

Rhode Island
      Brown University, Providence,  Rhode Island,  02903,  United States
Brian Ott, MD,  Principal Investigator

South Carolina
      Medical University of South Carolina, North Charleston,  South Carolina,  29406,  United States
Jacobo E. Mintzer, MD,  Principal Investigator

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Rachelle Doody, MD, PhD,  Principal Investigator

      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390,  United States
Anne Lipton, MD, PhD,  Principal Investigator

Vermont
      The Memory Clinic at Southwestern Vermont Medical Center, Bennington,  Vermont,  05201,  United States
Paul Solomon, PhD,  Principal Investigator

Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53706,  United States
Sterling Johnson, PhD,  Principal Investigator

Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  V6T 2B5,  Canada
Howard Feldman, MD,  Principal Investigator

Canada, Ontario
      Parkwood Hospital, London,  Ontario,  Canada
Michael Borrie, MD,  Principal Investigator

      Saint Joseph's Hospital, London,  Ontario,  Canada
Andrew Kertesz, MD,  Principal Investigator

      Sunnybrook and Women's College, Health Sciences Centre, University of Toronto, Toronto,  Ontario,  Canada
Sandra Black, MD,  Principal Investigator

Canada, Quebec
      Jewish Hospital Memory Clinic, Quebec, Montreal,  Quebec,  H3T 1E2,  Canada
Howard Chertkow, MD,  Principal Investigator

Study chairs or principal investigators

Michael W. Weiner, MD,  Principal Investigator,  University of California, San Francisco   
Ronald Petersen, MD, PhD,  Principal Investigator,  Mayo Clinic, Rochester, Minnesota   
Leon J. Thal, MD,  Principal Investigator,  University of California, San Diego   

More Information

ADEAR Center

Alzheimer's Disease Cooperative Study

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. Review. No abstract available.

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.

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

Study ID Numbers:  IA0068; 1U01AG024904
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  March 31, 2005
ClinicalTrials.gov Identifier:  NCT00106899
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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