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PREVENTION INSTRUMENTS

Background and Significance
Over the past 10 years, the ADCS has helped advance the state of the art in treatment of Alzheimer's Disease by conducting novel trials aimed at symptomatic improvement and slowing disease progression. In order to facilitate this important work, the ADCS also advanced the state of the art in measuring treatment efficacy through the development of new or improved Alzheimer's Disease assessment instruments.

Now that the Alzheimer's Disease treatment field is turning to exciting research designs and compounds, it is necessary to attend to increasing the efficiency and reducing the cost of assessments designed for use in future primary prevention trials. The ADCS plans to further this work in the latest ADCS primary prevention trial for Alzheimer's Disease.


What is the main objective of this study?
To conduct a "simulated" Alzheimer's Disease prevention clinical trial in 650 healthy, nondemented elderly subjects who are 75 years or older. The results of this simulated prevention trial will be used in the validation of the new, experimental outcome measures. The primary outcome of the simulated prevention trial is conversion to dementia, based on DSM IV criteria.

What are the secondary objectives of this study?
The other objectives of this study are:
  • To assess the reliability, efficiency, validity and sensitivity to early Alzheimer's Disease, to Mild Cognitive Impairment and to longitudinal change of new, mostly self-administered instruments that are designed for use in AD prevention trials. The new instruments provide evaluations in each of the five domains: cognitive function, activities of daily living, global change, quality of lives and pharmacoeconomics. They will be evaluated in comparison with clinical outcome and standard assessments obtained from the 650 non-demented elderly subjects participating in the four year simulated prevention trial
  • To evaluate and compare two methods of data acquisition: (a) assessments done at the clinic, and (b) mail-in assessments done at home. For the cognitive domain, the assessments will be staff administered either at the clinic or at home via telephone. In addition to their annual clinic visits for the simulated prevention trial, 600 subjects will be randomized to complete the new, experimental instruments annually, 300 at their clinic visits and 300 at home, following their clinic visit
  • To separately evaluate the performance of a brief, mail-in, cognitive function screening instrument for incident dementia. This screening instrument was developed as an efficient dementia screen for use in simple, very large AD prevention trials and will be completed at home by all participants
  • To conduct a pilot evaluation of the feasibility and utility of web based data acquisition of the new assessments. 50 additional subjects who have access to a computer and the Internet will participate in this pilot study

How will this study be conducted?
This is a four year simulated primary prevention study. Participants will be randomly assigned to each data acquisition method. The two data acquisition methods are either data obtained at the clinics or data obtained via mail.

How many patients will be participating in this study?
A total of 650 patients will be recruited for the study with 15 patients from USC. 12 patients were actually enrolled in this study.

What is the selection criteria for the subjects in this study?
The following are the subject selection criteria for this study:
  • 650 nondemented individuals
  • English or Spanish speaking men and women from the U.S.
  • Subjects will be 75 years or older
  • Subjects will be in good physical and mental health



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