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)

Further Study Details: 

Expected Total Enrollment:  800

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.

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

Alabama
      University of Alabama, Birmingham, Birmingham,  Alabama,  35233-0017,  United States
Arizona
      Sun Health / Arizona Consortium, Sun City,  Arizona,  85351,  United States
      Banner Good Samaritan Medical Center, Phoenix,  Arizona,  85006,  United States
California
      Stanford University, Stanford,  California,  94304,  United States
      University of California, Davis, Sacramento,  California,  95817,  United States
      University of California, Irvine, Irvine,  California,  92697-4285,  United States
      University of California, Los Angeles, Los Angeles,  California,  90095,  United States
      University of California, San Diego, La Jolla,  California,  92037,  United States
      University of California, San Francisco, San Francisco,  California,  94115,  United States
      University of Southern California, Los Angeles,  California,  90033,  United States
      University of California, Irvine - Brain Imaging Center, Irvine,  California,  92697,  United States
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06511,  United States
District of Columbia
      Georgetown University, Washington,  District of Columbia,  20057,  United States
Florida
      Mayo Clinic, Jacksonville, Jacksonville,  Florida,  32224,  United States
      Premiere Neurological Group, West Palm Beach,  Florida,  33407,  United States
      Wein Center, Miami,  Florida,  33140,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      Rush University Medical Center/Presbyterian St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana University, Indianapolis,  Indiana,  46202-5120,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287-7218,  United States
Massachusetts
      Boston University Schools of Medicine and Public Health, Boston,  Massachusetts,  02118,  United States
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      Mayo Clinic, Rochester, Rochester,  Minnesota,  55901-0144,  United States
Missouri
      Washington University, St. Louis,  Missouri,  63108,  United States
Nevada
      University of Nevada School of Medicine, Las Vegas,  Nevada,  89102,  United States
New Hampshire
      Dartmouth Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States
New York
      Columbia University, New York,  New York,  11032,  United States
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
      New York University, New York,  New York,  10016,  United States
      University of Rochester Medical Center, Rochester,  New York,  14620,  United States
      Albany Medical College, Albany,  New York,  12208,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27705,  United States
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44120,  United States
      Ohio State University, Columbus,  Ohio,  43210,  United States
Oregon
      Oregon Health and Science University, Portland,  Oregon,  97239,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
Rhode Island
      Brown University, Providence,  Rhode Island,  02903,  United States
South Carolina
      Medical University of South Carolina, North Charleston,  South Carolina,  29406,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390,  United States
Vermont
      The Memory Clinic at Southwestern Vermont Medical Center, Bennington,  Vermont,  05201,  United States
Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53706,  United States
Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  V6T 2B5,  Canada
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,  H3T 1E2,  Canada

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   

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