Study directory: John Olichney, MD

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

Recruiting Sites?
UC Davis-Alzheimer’s Disease Center @ Martinez VA: YES
UC Davis-Alzheimer’s Disease Center @ UCDMC: NO
Official study title: Alzheimer’s Disease Neuroimaging Initiative-2 (ADNI-2)

Conditions studied: Mild Cognitive Impairment (MCI), Alzheimer’s disease (AD) and Healthy Aging.

Purpose: The goal of this study is to determine the relationship among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer’s disease (AD), as the pathology evolves from normal aging, mild cognitive impairment (MCI), to dementia. ADNI-2, will provide additional information about the identification of diagnostic and prognostic markers, identify outcome measures and most effective clinical trial scenarios.

Eligibility

Inclusion criteria: Participants must be between the ages of 55 and 90 and be in good general health with memory problems or concerns. Participants will need a reliable study partner who has frequent contact with the participant, and who can accompany the participant to research visits as needed. Participant must be willing and able to undergo all test procedures including neuroimaging, and lumbar puncture and agree to longitudinal follow-up.

Exclusion criteria: Any significant neurological disease other than Alzheimer’s disease including Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy (PSP), seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma. Any significant systemic illness or unstable medical condition, or pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. Longstanding history of alcohol or substance abuse, or history of major depression, bipolar disorder or schizophrenia that puts assessment of cognitive impairment into question. Clinically significant abnormalities in B12, RPR or TFTs that might interfere with the study.

What is Involved?

Testing: Neurological and physical examinations; interview and study partner; MRI’s; FDG-PET;AV-45 PET; cognitive testing; detailed family history; blood and urine specimen collection for cell line generation and biomarker analysis; lumbar punctures (LP) for CSF specimen collection and biomarker analysis; questionnaires for participant and study partner.

Frequency of visits: After an initial screening visit and MRI, there will be a baseline visit, a 3-month, 6-month visit, and then 1 visit every 12 months for 54 months from the baseline Materials needed prior to evaluation: None

Cost: No costs will be charged for any of the study procedures. Participants will be sent a check for $50.00 for every clinic visit and $200 for every lumbar puncture, $25.00 for each MRI, $25.00 for each FDG-PET, and $50.00 for each AV-45 PET. The participant will also receive a $50.00 gift card once a year.

Contact Information

Coordinator: Katharine Vierira, RN, MS, NP- kevieira@ucdavis.edu, 925-372-2493

Assistant Coordinator: Adi Rabb Kondonijakos, M.A.- arabb@ucdavis.edu, 925-372-2464