P4-396: Arizona Alzheimer's research registry part one: Rationale and design

Discovery efforts have yielded numerous potential therapies for AD; there is now an imperative to develop these for AD treatment and prevention. Clinical trials must incorporate state-of-the-art methods, imaging techniques, and assure rapid, high volume, and high-quality enrollment. The Arizona Alzheimer's Consortium (AAC) created a Clinical Therapeutics Core to address this need. Components include 1) a campaign to raise public awareness about dementia related research; 2) a registry of people with or without dementia who are interested in clinical trials participation; 3) a process to strengthen AAC alliances and research capabilities, and 4) initial efforts to achieve common regulatory and contracts processes. The Arizona Alzheimer's Registry was developed in 2006, during which time we created a relational database and inventoried clinical trials resources across the AAC, and defined enrollment, screening, and referral processes. It was launched in 2007. Potential participants (PP) > age 49, with or without cognitive concerns, access the Registry via outreach events, telephone, or the Internet (www.registry.azalz.org). An initial intake form is completed and questions are addressed by telephone. Interested PP's receive a welcome packet, consent form, and medical history form; these are reviewed by telephone upon their return. Cognitive screening occurs via a cognitive and functional questionnaire and the modified Telephone Interview based Cognitive Screen (TICSm); those with ambiguous scores undergo a version of the Auditory Verbal Learning Task (Rey AVLT). Based on review of medical information and testing, PP's are categorized as probably cognitively normal, possibly cognitively impaired, or probably demented, and referred to existing AAC studies or held for future referral. The database stores PP contact information, research interest, cognitive status, demographics and referral information. After consent, it is used to track and facilitate PP enrollment and contacts, store comprehensive medical information, facilitate cognitive testing, and initiate and track study referrals with the AAC. It also catalogues clinical study and site information for all AAC sites. A companion presentation (Arizona Alzheimer's Registry II: Progress and Data from Year 1; Holt et al) summarizes the unexpected early success of this initiative, which may offer a model for other organizations.