The BIOCARD Study is a longitudinal study that was initiated in 1995 in the National Institute of Mental Health (NIMH) Intramural Research Program that assessed the ability of clinical, neuropsychological, and neuropsychiatric evaluations, neuroimaging, and fluid biomarkers to understand and predict progression from normal cognition to mild cognitive impairment (MCI) and dementia, particularly Alzheimer's disease (AD). It enrolled cognitively normal individuals who were first degree relatives of family members who had dementia. Average age at entry was 55 years, and these participants received cognitive testing every year, a full cognitive battery every two years, and a magnetic resonance imaging (MRI) scan and a lumbar puncture for collection of cerebral spinal fluid (CSF) every 2-4 years. As of 2005, some participants had been followed for up to 10 years. In 2005, the BIOCARD Study was suspended. In October, 2006 representatives of the National Institute on Aging (NIA) and NIMH met to review the BIOCARD study, and as the result of that meeting there was a decision to convene a group of experts with the charge to provide advice about whether this study was of sufficient scientific interest and importance that NIA/NIMH should consider extending the study to collect data on available participants who would consent to be followed. The meeting of experts was held by teleconference in April, 2007, and the recommendation of the group was that the BIOCARD Study was an extremely valuable study with a wealth of information already collected, that the participants were highly motivated individuals, and that the NIA/NIMH should consider extending the BIOCARD study to collect additional cognitive and dementia outcomes. However, they also indicated that information would have to be provided regarding the number of individuals who would potentially agree to further participation. In June, 2007 NIMH sent out letters to about 350 BIOCARD participants potentially available for follow-up to ask if they would be interested in continuing their participation in the study, and about 200 indicated that they would be interested. Based on the recommendations of the expert group and on the response to the survey of BIOCARD participants, in September, 2007 the National Advisory Council on Aging approved the development of this RFA to extend the clinical and neuropsychological evaluations of the BIOCARD participants who will consent to be followed. In addition, all of the previous clinical and neuropsychological data which have been collected, the biological samples which have been stored (plasma, CSF), and the MRI data from consenting participants will be provided to the successful grantee with the provision that a system will be set up to share these data and samples with the greater scientific community as well as the data and samples that will be collected during this extension period.
