Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

All New Participants

• Good general health
• Study partner who has frequent contact with participant (minimum average of 10 hours per week) and can accompany participant to clinic visits
• Modified Hachinski Ischemic Score of less than or equal to 4; Geriatric Depression Scale score of less than 6
• Completion of six grades of education or good work history 
• Willing to undergo repeated MRIs, at least two PET scans, blood collection, and at least one lumbar puncture 
• Willing to share genetic data and biomarker samples
• Fluent in English or Spanish

Cognitively Normal Participants

• Cognitively normal, based on absence of significant impairment in cognitive function or activities of daily living (currently recruiting non-Caucasian participants only for the normal cognition group)
• With or without subjective memory complaints 
• Normal memory function score; Mini-Mental State Examination (MMSE) score of 24-30 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0; Memory Box score of 0

Participants with MCI

• Subjective memory concern reported by participant, study partner, or clinician
• Abnormal memory function score; MMSE score of 24-30 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0.5; Memory Box score of at least 0.5
• General cognition and functional performance such that a diagnosis of Alzheimer's disease cannot be made by the site physician
• Permitted medications if taking at least 4 weeks: stable dose of antidepressants lacking significant anticholinergic effects, cholinesterase inhibitors or memantine, estrogen replacement therapy, gingko biloba; must discontinue psychoactive medications at least 4 weeks before screening

Participants with Alzheimer’s Disease

• Subjective memory concern reported by participant, study partner, or clinician
• Abnormal memory function score; MMSE score of 20-24 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0.5 or 1.0
• Meets criteria for probable Alzheimer’s disease
• Permitted medications if taking at least 4 weeks: same as for MCI above

• Significant neurological 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 neurological deficits or known structural brain abnormalities
• Screening/baseline MRI brain scan with evidence of infection, infarction or other focal lesions, or multiple lacunes or lacunes in a critical memory structure
• Contraindications to MRI including pacemaker or metal fragments or foreign objects in the eyes, skin, or body
• Major depression or bipolar disorder within the past year; psychotic features, agitation, or behavioral problems within the last 3 months; history of schizophrenia
• Current treatment for obsessive-compulsive disorder or attention deficit disorder
• Alcohol or substance abuse/dependence within the past 2 years
• Any significant systemic illness or unstable medical condition that could lead to difficulty participating in the study
• Pregnant, lactating, or of childbearing potential (women must be 2 years postmenopausal or surgically sterile)
• Clinically significant abnormalities in B12 or thyroid function tests
• Prohibited medications: psychoactive medications (certain antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics); warfarin or other anticoagulants (such as dabigatran, rivaroxaban, and apixaban); investigational agents 1 month prior to entry and during the study
• Residence in skilled nursing facility
• Participation in clinical studies involving neuropsychological measures collected more than one time per year

ADNI3 extends the work of previous studies, first launched in 2004, to inform the design of therapeutic trials in Alzheimer’s disease. ADNI3 will continue ADNI's goals to identify diagnostic and prognostic markers of disease, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trials.

Up to 1,200 new participants are being sought for ADNI3. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three groups of participants: cognitively normal, MCI, and mild Alzheimer’s dementia. Investigators will evaluate changes in participants' cognition (including memory, reasoning, and language). Participants will undergo clinical, cognitive, and genetic tests, as well as positron emission tomography (PET) and magnetic resonance imaging (MRI) scans and cerebrospinal fluid collection for up to 5 years.

Investigators will also assess changes in brain structure, amyloid and tau deposits in the brain (two hallmarks of Alzheimer’s disease), the rate of conversion to MCI or dementia due to Alzheimer’s, and changes in glucose metabolism and tau biomarkers in cerebrospinal fluid.

To find out more information about the ADNI3 study, please visit www.ADNI3.org.

University of Southern California

• Northern California Institute of Research and Education
• National Institute on Aging (NIA)
• Alzheimer's Therapeutic Research Institute