Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

What Is This Study About?

The purpose of ADNI2 is to examine how brain imaging and other biomarkers can be used to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease. Together with previous studies ADNI1 and ADNI-GO, ADNI2 seeks to determine the relationships among brain imaging results, biomarkers, and clinical, cognitive, and genetic characteristics of the entire spectrum of Alzheimer's as it evolves from normal aging through dementia. The overall goals are increased knowledge concerning the sequence and timing of events leading to MCI and Alzheimer's disease, better methods for early detection of these conditions, and data that informs clinical trials aimed at slowing disease progression.

Do I Qualify To Participate in This Study?

Must have:

All Participants

• Age 55-90, with a minimum age of 65 for the normal control group and the significant memory concern group
• Study partner who has frequent contact with the participant (an average of 10 hours per week or more) and can accompany the participant to all clinic visits
• Seeing and hearing ability adequate for neuropsychological testing
• Good general health
• Participant is not pregnant, lactating, or of childbearing potential (women must be 2 years postmenopausal or surgically sterile)
• Six grades of education or a good work history (sufficient to exclude mental retardation)
• Must speak English or Spanish fluently
• No medical contraindications to MRI
• Stability of permitted medications for 4 weeks; in particular, participants may take antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, gingko biloba (permissible but discouraged); washout from psychoactive medication for at least 4 weeks prior to screening
• Hachinski score of less than or equal to 4; Geriatric Depression Scale less than 6

Cognitively Normal Participants

• Free of memory complaints
• Normal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0; Memory Box score = 0
• Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living

Signicant Memory Concern Participants

• Significant subjective memory concern as reported by subject, study partner, or clinician and confirmed by Cognitive Change Index of 16
• Normal memory function score on Wechsler Memory Scale (adjusted for education); Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0; Memory Box score = 0
• Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
• Medications permitted if stable for 4 weeks, including: antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, gingko biloba (permissible but discouraged); washout from psychoactive medication (such as excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics) for at least 4 weeks prior to screening

EMCI and LMCI Participants

• Subjective memory concern as reported by participant, study partner, or clinician
• Abnormal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0.5; Memory Box score = 0.5 or higher
• General cognition and functional performance such that a diagnosis of AD cannot be made by the site physician
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening

Alzheimer's Disease Participants

• Subjective memory concern as reported by subject, study partner, or clinician
• Abnormal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 20-26; Clinical Dementia Rating (CDR) = 0.5 or 1.0
• Meets criteria for probable Alzheimer's disease
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening

Follow-up Participants from ADNI1 and ADNI-GO

• Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of cognitively normal, MCI, or EMCI regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI
• Willing and able to continue to participate; a reduced battery of tests is allowable if the subject is not able/willing to complete the full battery
• 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

Must NOT have:

• Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; subjects 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 or bipolar disorder
• History of schizophrenia, alcohol or substance abuse or dependence within the past 2 years, or any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
• Residence in skilled nursing facility
• Participation in clinical studies involving neuropsychological measures collected more than one time per year
• Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure would exceed allowable limits
• Prohibited medications: Current use of specific psychoactive medications (such as certain antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics), warfarin or dabigatran (exclusionary for lumbar puncture), medication for obsessive-compulsive disorder or attention deficit disorder; use of investigational agents one month prior to entry and for the duration of the study
• Significant neurologic disease as follows:
  • Normal controls and significant memory concern participants: conditions including 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
  • EMCI and LMCI participants: significant neurologic disease other than suspected incipient Alzheimer's, including any conditions listed above for normal controls
  • Alzheimer's disease participants: diseases other than Alzheimer's including those listed above for normal controls
  • Follow-up participants from ADNI1 and ADNI GO: participants will not be able to participate in amyloid imaging with Florbetapir F 18 if they have had any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed federal limits.

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Who Sponsors This Study?

Lead: University of Southern California, Alzheimer's Therapeutic Research Institute

Collaborator Sponsor

• Northern California Institute for Research and Education (NCIRE)
• National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT01231971