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 goal of this protocol is to continue successful efforts to develop new or improved instruments and assessment methods for evaluating clinical effectiveness in Alzheimer's disease clinical trials. Improved evaluation of treatment efficacy is necessary to optimize determination of whether a drug has a therapeutic effect, whether the effect observed is clinically meaningful and of sufficient magnitude to outweigh possible risks, and finally, whether treatment has a favorable socioeconomic impact. Our current instrument efforts will focus on methods for evaluating change in nondemented elderly subjects participating in primary prevention trials. In a longitudinal study involving 600 normal elderly subjects who will participate in a simulated primary prevention trial, we will examine the reliability, validity, and longitudinal sensitivity of the new measures, and compare the efficiency of the two methods of data acquisition - assessments obtained at the clinic, and assessments via mail, done at home following the clinic visit. Three hundred subjects will be randomly assigned to each data acquisition method. Self-administered assessments done as part of the clinic visit should require less staff time and cost than interview-based instruments. However, the clinic visit itself is a costly component of a large sample, long duration primary prevention trial. Assessment via mail would require less staff time and would be a more cost efficient approach, but the feasibility, reliability and validity of this method needs to be determined. Since reminders, minimal assistance and brief cognitive test administration via telephone might enhance the reliability and validity of at-home assessment, we will include a telephone contact as part of the at-home data acquisition condition. The instruments for global, ADL, QOL and pharmacoeconomic assessments will all be entirely self-administered in order to minimize staff involvement. For the cognitive domain, the potential sensitivity of the evaluation will be enhanced by including a brief set of test questions (3-5 minutes) to be administered by site staff. For all domains, involvement of study staff will include dispensing and collecting instruments (in person or by mail); answering any questions (in person or via telephone); reminding the subject to complete and return the forms (at-home condition); checking the completed forms for accuracy and completeness, and communicating with the subject and/or study partner to collect any missing information (in person or via telephone). For the cognitive domain, site staff will also administer the brief set of cognitive test questions (either at the clinic or via telephone, depending on group assignment). A third potential acquisition method, using the Internet, will also be explored in a separate group of 50 subjects. Having study subjects do their self-assessments interactively on the web using a computer or 'Internet appliance' would greatly reduce staff time, enhance data consistency and quality control, and substantially reduce the need for data monitoring at the sites and for data entry at the ADCS Coordinating Center. Currently, there are limitations to use of the web for data acquisition in AD trials. These include the lack of adequate use of computers and the Internet by the elderly (in 1999, about 8% of people over 65 in the Unites States were using the web), and the limited availability to the elderly of web access. However, these limitations should be greatly reduced in the future. Rapid technological advances are continuing to reduce hardware and web access costs, and to increase the speed and availability of web access. Furthermore, Internet use by the general public is increasing geometrically, particularly among the elderly. For example, a recent report (International Data Corp., 2000) found that those over 55 are the fastest-growing group of Internet users. More than 12 million seniors are linked to the Internet, up 106% over last year. These numbers are forecasted to more than triple over the next 5 years, reaching 34 million by 2004 and accounting for 20% of all new Internet users. Contributing factors cited include simplified and less expensive computers, easier email access, computer courses at senior centers and elsewhere, and wiring of some senior housing facilities or high-speed Internet access. Thus it should be possible in the foreseeable future to conduct large primary prevention trials at greatly reduced cost using web based assessment and data acquisition. To explore how web technology can facilitate AD primary prevention trials, we will conduct a pilot feasibility study of web-based versions of the new instrument in a subset of elderly subjects participating in the Primary Prevention Trial who currently use computers and the Internet. In studies involving subjects with dementia, investigators frequently rely heavily or exclusively on proxies to obtain information about subjects. There are situations in which persons with dementia can provide needed information themselves or in which direct observation or testing of the subject can be used to obtain information. However, proxy informants (very often family caregivers) frequently must be asked to report on subject cognition, function and behavior. Unfortunately, relatively little research has been done on the use of proxies in dementia research (Magaziner, 1997). Several studies have documents that informants rate elderly subjects as more impaired than subjects rate themselves. However, few of these studies controlled for the cognitive status of the subject or informant or incorporated direct measures of subject or informant impairment. Studies of cognitively impaired elders show similar results, although in most, no attempt is made to assess awareness of deficits in persons with dementia. The current Prevention Instrument (PI) offers a unique opportunity to assess the impact of informant (proxy) characteristics on the validity of subject assessments. At the start of the study, all subjects will be free of dementia; some subjects will develop dementia during the study. Over the course of the study we will be able to track discrepancies between subject and proxy reports, and assess the relationship of discrepancies to level of impairment in the subject and characteristics of the proxy. The influence of the informant (study partner) characteristics on subject assessments will focus particularly on QOL, a domain in which both the informant and subject may be affected as dementia changes. All Prevention Instrument Protocol participants will have the opportunity to participate in a book club. The purpose of the book club is to learn about the relationship between reading and healthy mental aging.
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