(SD = 9.five) plus the mean Baseline MMSE was 19.five (SD = 3.1). Baseline participant characteristics
(SD = 9.five) and the mean baseline MMSE was 19.five (SD = 3.1). Baseline participant qualities of the cohort didn’t differ considerably by study group (Table 1).Primary outcome measureResultsParticipant flowThe trial was conducted amongst 26 March 2009 and 3 March 2011, including 18 months of recruitment. In the 703 participants who consented, 167 were excluded simply because they didn’t meet the inclusion criteria and nine withdrew in the study before randomization (Figure 1). The resulting 527 participants were randomized to Souvenaid (active item, n = 265) or manage solution (n = 262). Compared using the intent-to-treat sample, 3 subjects had been excluded in the all-subjects-treated population simply because they had not taken any study solution. With the 527 subjects who were randomized, 76 (14.four ) withdrew from the study early (n = 37 (14.0 ) subjects from the active study group; n = 39 (14.9 ) subjects in the handle group). Baseline characteristics are summarized in Table 1. Randomized participants had a imply age of 76.7 years (SD = eight.2), and a imply education level (defined as number of years right after finishing major school) of 6.5 years (SD = three.5). Girls comprised 52 in the cohort and 94 of participants have been White (such as Hispanics). The imply time from initial AD diagnosis was 33.eight months (SD = 27.four). The mean duration of AD medication use was 30.1 months (SD = 25.9); 34 of participants have been taking an acetylcholinesterase inhibitor agent only, 6 were taking memantine only, and 60 were on both remedies.ADAS-cog data are presented in Table two and Figure 2. ADAS-cog scores showed an increase over time in both study groups, indicating cognitive decline, c-Rel Inhibitor Species without the need of important differences among the active and control group over 24 weeks (between-group distinction of 0.37 points, common error = 0.57, P = 0.513, mixed Bcl-B Inhibitor Gene ID models for repeated measures). The conclusions had been unchanged in a subsequent model that corrected for pre-specified confounders.Secondary outcome measuresNo variations between study groups have been observed over 24 weeks in functionality around the cognitive test battery, the Alzheimer’s Disease Cooperative Study Activities of Every day Living, plus the Clinical Dementia Rating Sum of Boxes (Table two). Mean compliance was 94.1 (SD = 11.9) for the active group and 94.five (SD = 13.2) for the handle group (P = 0.689 for between-group difference, t test). A important uptake of docosahexaenoic acid (Figure 3a) and eicosapentaenoic acid in to the erythrocyte membranes, elevated plasma vitamin E levels (Figure 3b) and decreased homocysteine levels were observed for the active group compared together with the control group over the 24-week intervention period (P 0.001, Mann hitney U test).Security and tolerabilityThe 24-week study completion rate was 86 (n = 228) within the group receiving active product and 85 (n = 223) inShah et al. Alzheimer’s Investigation Therapy 2013, five:59 alzres.com/content/5/6/Page 5 ofTable 1 Baseline participant traits by study groupCharacteristic Demographics Age (years) Female Education immediately after finishing main college White (such as Hispanic) Imply time from initial AD diagnosis (months) Duration of AD medication use (months) Type of AD medication utilized Acetylcholinesterase inhibitor Memantine Acetylcholinesterase inhibitor and memantine combined Body mass index (kg/m2) Mini-Mental State Examination score (out of 30) Presence of apolipoprotein E 4 allele No Yes UnknownData presented as imply (regular deviation) or.