Alzheimer's Disease Neuroimaging Initiative 2

Completed

Conditions studied: Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), Significant Memory Concern (SMC), Early Mild Cognitive Impairment (EMCI), Late Mild Cognitive Impairment (LMCI)

In brief

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), 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). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

Key facts

Study ID

NCT01231971

Run by

University of Southern California

People needed

1182

Starts

2011-02-14

Expected to finish

2017-11-29

Last updated by the study team

2024-11-21

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants will be classified as either normal controls, SMC, EMCI, LMCI or AD participants. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
• General (applies to each category):
• Geriatric Depression Scale less than 6.
• Age between *55-90 (inclusive). *For normal controls and SMC participants, age must be between 65-90.
• Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.
• Visual and auditory acuity adequate for neuropsychological testing.
• Good general health with no diseases expected to interfere with the study.
• Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
• Willing and able to participate in a longitudinal imaging study.
• Hachinski less than or equal to 4.
• Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
• Must speak English or Spanish fluently.
• Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one Amyloid imaging) and no medical contraindications to MRI.
• Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing and DNA and RNA banking.
• Agrees to collection of blood for biomarker testing.
• Agrees to at least one lumbar puncture for the collection of CSF.
• Specific Inclusion Criteria for normal controls:
• Participant must be free of memory complaints, verified by a study partner.
• Normal memory function score on Wechsler Memory Scale (adjusted for education)
• Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
• Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
• Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
• Stability of Permitted Medications for 4 weeks. In particular, participants may take:
• Antidepressants lacking significant anticholinergic side effects
• Estrogen replacement therapy is permissible

You may not qualify if…

• General (applies to each category):
• Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded
• 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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
• Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
• 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
• Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); Current use of warfarin or dabigatran (exclusionary for lumbar puncture).
• 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
• Exclusion for FDG PET scan and amyloid imaging with Florbetapir F 18: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
• Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director
• Specific Exclusion Criteria for normal controls and SMC participants:
• Any significant neurologic 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
• Specific Exclusion Criteria for EMCI and LMCI participants:
• 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.
• Specific Exclusion Criteria for AD participants:
• Any significant neurologic disease other than 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.
• Specific Exclusion Criteria for follow-up participants from ADNI1 and ADNI GO:
• Participants will not be able to participate in FDG PET scan and amyloid imaging with Florbetapir F 18 if the following is true: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Martinez, California, United States
• University of California, Irvine (Brain Imaging Center) — Orange, California, United States
• Stanford University / PAIRE — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Howard University — Washington D.C., District of Columbia, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Wien Center for Clinical Research — Miami Beach, Florida, United States
• USF Health Byrd Alzheimer's Institute — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Alabama, Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.