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From Merck Research Laboratories (Drs. Lines, McCarroll, and Block), West Point, PA, and Albert Einstein College of Medicine (Dr. Lipton), Bronx, NY.
Address correspondence and reprint requests to Dr. C.R. Lines, Merck Research Laboratories, 10 Sentry Parkway, Blue Bell, PA 19422; e-mail: chris_lines{at}merck.com
Objectives: To evaluate the utility of telephone screening for identifying subjects with amnestic mild cognitive impairment (aMCI) for enrollment in a clinical trial and to identify which elements of the modified Telephone Interview for Cognitive Status (TICS-m) best predicted the in-clinic determination of aMCI.
Methods: Subjects aged
65 years with memory complaints responded to an advertisement for a clinical trial by calling a central telephone recruiting agency. To determine eligibility, subjects went through a stepwise selection procedure involving a review of major protocol inclusion and exclusion criteria, followed by administration of the Category Fluency Test (CFT) and then the TICS-m. Subjects meeting entry criteria, who obtained a score of
13 on the CFT for "animals" and
24 on the CFT for "animals" and "fruits" and who scored between 19 and 38 on the TICS-m, were referred for a clinic appointment to determine whether they met clinical criteria for aMCI. Clinical criteria for aMCI required a score of
24 on the Mini-Mental State Examination and a score of
37 on the Rey Auditory Verbal Learning Test. A post hoc analysis was performed using factor analysis and logistic regression models to investigate which elements of the TICS-m best predicted the in-clinic determination of aMCI.
Results: Of 16,988 subjects who called the telephone agency, 8,742 passed the review of inclusion/exclusion criteria; 6,090 met the CFT cut scores and received the TICS-m; 5,223 met cut scores on the TICS-m and were referred for an in-clinic appointment; 747 were seen in the clinic; and 324 met clinical criteria for aMCI. Factor analysis indicated three factors on the TICS-m: language/attention, orientation, and memory. The memory factor, comprising immediate and delayed recall of a word list, was the most important contributor for identifying subjects who met clinical criteria for aMCI.
Conclusion: Only 2% of subjects who underwent telephone screening were recruited into the study, but 43% of those who passed telephone screening and were seen in the clinic met clinical criteria for aMCI. The word recall tests of the TICS-m were the most important items for identifying which subjects met clinical criteria for aMCI.
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