ADNI: Alzheimer's Disease Neuroimaging Initiative
- Conditions
- Alzheimer's Disease
- Interventions
- Procedure: Magnetic Resonance Imaging (MRI)Procedure: Positron Emission Tomography (PET)Procedure: Lumbar Puncture (LP)
- Registration Number
- NCT00106899
- Lead Sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 818
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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Lumbar Puncture (LP) Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months 1 Positron Emission Tomography (PET) Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months 2 Lumbar Puncture (LP) Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months 3 Positron Emission Tomography (PET) Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months 3 Lumbar Puncture (LP) Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months 2 Magnetic Resonance Imaging (MRI) Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months 3 Magnetic Resonance Imaging (MRI) Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months 2 Positron Emission Tomography (PET) Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months 1 Magnetic Resonance Imaging (MRI) Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
University of California, Irvine
🇺🇸Irvine, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Sun Health / Arizona Consortium
🇺🇸Sun City, Arizona, United States
University of California, Irvine - Brain Imaging Center
🇺🇸Irvine, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Olin Neuropsychiatry Research Center
🇺🇸Hartford, Connecticut, United States
Stanford University
🇺🇸Stanford, California, United States
Premiere Neurological Group
🇺🇸West Palm Beach, Florida, United States
Mayo Clinic, Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Neurological Care of CNY
🇺🇸Syracuse, New York, United States
Wake Forest University
🇺🇸Winston Salem, North Carolina, United States
Albany Medical College
🇺🇸Albany, New York, United States
Dent Neurological Institute
🇺🇸Orchard Park, New York, United States
Sunnybrook and Women's College, Health Sciences Centre, University of Toronto
🇨🇦Toronto, Ontario, Canada
Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
New York University
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Saint Joseph's Hospital
🇨🇦London, Ontario, Canada
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Parkwood Hospital
🇨🇦London, Ontario, Canada
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
Jewish Hospital Memory Clinic, Quebec
🇨🇦Montreal, Quebec, Canada
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center/Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston University Schools of Medicine and Public Health
🇺🇸Boston, Massachusetts, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Wein Center
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Nevada School of Medicine
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Byrd Alzheimer's Institute
🇺🇸Tampa, Florida, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of California, Davis
🇺🇸Sacramento, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States