ADNI: Alzheimer's Disease Neuroimaging Initiative

Alzheimer's Disease Clinical Trial

Official title:

Alzheimer's Disease Neuroimaging Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106899
• Other study ID #: IA0068
• Secondary ID: 1RC2AG0365351U01
• Status: Completed
• Phase: N/A
• First received: March 31, 2005
• Last updated: September 15, 2014
• Start date: July 2005
• Est. completion date: June 2011

Study information

• Verified date: September 2014
• Source: Alzheimer's Disease Cooperative Study (ADCS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 90 Years

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Procedure:
• Magnetic Resonance Imaging (MRI)
MRI scans
• Positron Emission Tomography (PET)
PET scans
• Lumbar Puncture (LP)
collection of cerebrospinal fluid

Locations

Country	Name	City	State
Canada	Parkwood Hospital	London	Ontario
Canada	Saint Joseph's Hospital	London	Ontario
Canada	Jewish Hospital Memory Clinic, Quebec	Montreal	Quebec
Canada	Sunnybrook and Women's College, Health Sciences Centre, University of Toronto	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	Dent Neurological Institute	Amherst	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Boston University Schools of Medicine and Public Health	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	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	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Olin Neuropsychiatry Research Center	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	University of California, Irvine - Brain Imaging Center	Irvine	California
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	University of California, San Diego	La Jolla	California
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Wein Center	Miami	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University	New York	New York
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	Dent Neurological Institute	Orchard Park	New York
United States	Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California, Davis	Sacramento	California
United States	University of California, San Francisco	San Francisco	California
United States	Washington University	St. Louis	Missouri
United States	Stanford University	Stanford	California
United States	Sun Health / Arizona Consortium	Sun City	Arizona
United States	Neurological Care of CNY	Syracuse	New York
United States	Byrd Alzheimer's Institute	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia
United States	Premiere Neurological Group	West Palm Beach	Florida
United States	Wake Forest University	Winston Salem	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
Alzheimer's Disease Cooperative Study (ADCS)	Alzheimer's Association, Alzheimer’s Drug Discovery Foundation, Foundation for the National Institutes of Health, National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute on Aging (NIA), Northern California Institute of Research and Education

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. Review. — View Citation

External Links

•   Alzheimer's Disease Cooperative Study
•   Laboratory of Neuro Imaging: Alzheimer's Disease Neuroimaging Initiative