This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The general objective is to continue to develop new or improved instruments and assessment methods for evaluation clinical effectiveness in Alzheimer's disease (AD) clinical trials. Utilizing 40 Alzheimer's Disease Centers, 650 non-demented elderly individuals (age 75 or older) will be enrolled in the study. Each site may enroll up to 48 participants, 20% of which must be minorities.
The aims of the study include: (1) assess the reliability, efficiency, validity, and sensitivity in detection early AD using new, mostly self-administered instruments that are designed for use in AD prevention trials. These instruments will be evaluated in comparison with clinical outcome and the standard assessments from the participants participating in the four-year study: (2) Evaluate and compare two methods of data acquisition: (a) assessments done at the clinic, and (b) mail in assessments done at home with assistance via telephone: (3) Conduct a pilot evaluation of the feasibility throughout all 40 sites, who have access to computer and the internet, will be randomized into this pilot study: and (4) Compare self-rate to proxy rate versions of some of the instruments. The following hypothesis will be evaluated: (1) the 2 primary data acquisition methods (and the piloted web method) will be adequately reliable; (2) The measures will show adequate validity with respect to measures in the main prevention trial and to measures in other assessment domains; (3) the measures will show good sensitivity to dementia conversion; (4) the assessment conditions will differ with respect to data quality and efficiency; (5) Proxy ratings will overestimate impairment and change relative to participant self-ratings. Participants and informants will attend the screening visit to assess if eligible for the study. If eligible, they will attend the baseline visit, in which they will complete a cognitive battery and have their blood drawn for ApoE and blood/DNA storage. At this point they will be randomized into the clinic group or home group. Participants in the Clinic Group will complete all forms at the clinic. Participants in the Home Group will complete forms via mail and internet. Following this they will complete a 3-month evaluation (either in the clinic or at home). Each year, they will complete an annual cognitive battery, with 6-month telephone follow-up calls to review health status.
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