The aim of the neuropsychological
testing was explained to the participants and they were instructed the same way on both days of testing Analysis of plasma escitalopram Plasma escitalopram was measured following 4 weeks of intervention. The extraction and quantitation of escitalopram was carried out on an ASPEC XL combined with a high-pressure liquid chromatography (HPLC) system, both from Gilson, Villiers le Bell, France. Method validation resulted in lower and upper limits of quantitation of 10 and 3,600nmol/l, respectively. The interassay coefficients of variation ranged from 5.5% to 8.4%, and trueness ranged from 93.2% to 103.0% within the measurement range. Extraction Inhibitors,research,lifescience,medical recovery was 38%, Inhibitors,research,lifescience,medical and carry-over was less than 1%. Statistical methods Data
analyses were described in a pre-established analysis plan [Knorr et al. 2009]. All randomized participants were analysed, including those with missing data at the testing after 4 weeks of intervention. Statistical analyses were planned as analysis of covariance (ANCOVA) [Vickers and selleck chemicals Altman, 2001] but if the mean of the change in the difference between the results for the general cognition score and factor scores before and after the intervention did not follow (and could not be transformed into) a normal distribution, the intervention groups were compared by a nonparametric test (Mann–Whitney U-test). Further, the outcomes Inhibitors,research,lifescience,medical were analysed as planned as the difference for the individual participants before and after the intervention,
first unadjusted and then adjusted for age, sex, Hamilton depression score at entry, and the Danish Adult Reading Test, and concentration of escitalopram in plasma, if they presented with a p-value<0.1 in the univariate analyses. Results Participant and non-participant Inhibitors,research,lifescience,medical characteristics The probands (n=466) gave us permission to contact 359 first-degree Inhibitors,research,lifescience,medical relatives, who were the potential participants in the trial. The participant flow, including reasons for exclusion, is shown in Figure 1. A total of 80 participants were included and randomized. The characteristics of the participants can be seen in Table 1. Table 1. Characteristics of the participants of the AGENDA trial at entry. Adherence to Annals of Internal Medicine the intervention One or two tablets were missed by five participants in the placebo arm and by six participants in the escitalopram arm. In the escitalopram arm two participants left the trial prior to onset of the intervention period: one man withdrew the informed consent and one female started steroid treatment due to recurrence of skin allergy. Further, data is missing for one man for the follow-up test, except for CAMCOG, due to the participant’s schedule problem. Full adherence to the protocol was stated by 32 participants in the placebo arm and by 33 in the escitalopram arm. Plasma escitalopram Blood was drawn from all 78 participants at follow up, but one test from the escitalopram group failed.