Alzheimer's Disease Neuroimaging Initiative Grand Opportunity

NCT01078636 | Completed DMC

• 2 other identifiers: IA01751RC2AG036535-01
• Study Type: observational
• Target: 342
• Locations: 2 countries
• Sites: 55

Brief Summary

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), 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). ADNI-GO seeks to define and characterize the mildest symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

amyloid; plaques; imaging; early detection; Amnestic MCI; pre-dementia

Outcome Measures

Primary Outcomes (1)

• Rate of Decline as measured by: Cognitive tests, Activities of Daily Living, and CDR Sum of Boxes

  at screening, baseline, 6 (EMCI only) and 12 months

Secondary Outcomes (8)

• Rate of conversion will be evaluated among all four groups

  at screening , baseline, 6 (EMCI only) and 12 months

• Rate of volume change of whole brain, hippocampus, and other structural MRI measures

  at screening and 3, 6, and 12 months (EMCI); at baseline and 12 months (follow-up patients)

• Rates of change on each specified biochemical biomarker

  at baseline, 6 (EMCI only) and 12 months

• Rates of change of glucose metabolism (FDG-PET)

  at baseline

• Extent of amyloid deposition as measured by 18F-AV-45

  at baseline

Study Arms (3)

EMCI (only cohort recruiting in this study)

Newly recruited early amnestic Mild Cognitive Impairment patients; estimated enrollment 200

LMCI (not recruiting in this study)

Late Mild Cognitive Impairment patients; approximately 400 LMCI participants anticipated to follow from the original ADNI study

CN (not recruiting in this study)

Cognitively Normal patients; approximately 200 CN participants anticipated to follow from the original ADNI study

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• Between 55 and 90 years of age
• Study partner to accompany patient to all clinic visits for the duration of the protocol
• Memory complaint by patient and/or study partner
• Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
• Mini-Mental State Exam score between 24 and 30 (inclusive)
• Clinical Dementia Rating = 0.5; Memory Box score at least 0.5
• General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
• Stability of the following permitted medications for 4 weeks (unless stated otherwise):
• Antidepressants lacking significant anticholinergic side effects
• Estrogen replacement therapy
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• Cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening
• Geriatric Depression Scale less than 6
• Visual and auditory acuity adequate for neuropsychological testing

You may not qualify if:

• Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure
• 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 as described in DSM-IV within the past 1 year
• Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
• History of schizophrenia
• History of alcohol or substance abuse or dependence within the past 2 years
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
• Clinically significant abnormalities in B12, or TFTs that might interfere with the study
• Residence in skilled nursing facility
• Use of investigational agents one month prior to entry and for the duration of the trial
• Participation in clinical studies involving neuropsychological measures being collected more than one time per year
• Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director

Sponsors & Collaborators

• Alzheimer's Disease Cooperative Study (ADCS): lead
• Northern California Institute of Research and Education: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (55)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, Irvine - BIC

Irvine, California, 92868, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Davis

Martinez, California, 94553, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California, San Diego

San Diego, California, 92037, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Wien Center

Miami Beach, Florida, 33140, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55901, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63108, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health (CCLRBC)

Las Vegas, Nevada, 89106, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Dent Neurological Group

Amherst, New York, 14226, United States

Location

New York University

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44122, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Butler Hospital Memory & Aging Program

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29406, United States

Location

University of Texas SWMC

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

Saint Joseph's Hospital

Hamilton, Ontario, N6A 4V2, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Jewish General Hospital / McGill University

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (5)

• Shen L, Kim S, Risacher SL, Nho K, Swaminathan S, West JD, Foroud T, Pankratz N, Moore JH, Sloan CD, Huentelman MJ, Craig DW, Dechairo BM, Potkin SG, Jack CR Jr, Weiner MW, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Whole genome association study of brain-wide imaging phenotypes for identifying quantitative trait loci in MCI and AD: A study of the ADNI cohort. Neuroimage. 2010 Nov 15;53(3):1051-63. doi: 10.1016/j.neuroimage.2010.01.042. Epub 2010 Jan 25.

  PMID: 20100581 BACKGROUND

• Risacher SL, Saykin AJ, West JD, Shen L, Firpi HA, McDonald BC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Baseline MRI predictors of conversion from MCI to probable AD in the ADNI cohort. Curr Alzheimer Res. 2009 Aug;6(4):347-61. doi: 10.2174/156720509788929273.

  PMID: 19689234 BACKGROUND

• Petersen RC, Aisen PS, Beckett LA, Donohue MC, Gamst AC, Harvey DJ, Jack CR Jr, Jagust WJ, Shaw LM, Toga AW, Trojanowski JQ, Weiner MW. Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization. Neurology. 2010 Jan 19;74(3):201-9. doi: 10.1212/WNL.0b013e3181cb3e25. Epub 2009 Dec 30.

  PMID: 20042704 BACKGROUND

• Misra C, Fan Y, Davatzikos C. Baseline and longitudinal patterns of brain atrophy in MCI patients, and their use in prediction of short-term conversion to AD: results from ADNI. Neuroimage. 2009 Feb 15;44(4):1415-22. doi: 10.1016/j.neuroimage.2008.10.031. Epub 2008 Nov 5.

  PMID: 19027862 BACKGROUND

• Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.

  PMID: 39324520 DERIVED

Related Links

• Laboratory of NeuroImaging: Alzheimer's Disease Neuroimaging Initiative

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, cerebrospinal fluid

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald Petersen, MD, PhD

  Mayo Clinic - Rochester, Minnesota

  STUDY CHAIR

• Michael W Weiner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Paul Aisen, MD

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (50); CA (5)