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P3‐033: RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED STUDY TO ASSESS TREATMENT OF BIIB092 IN SUBJECTS WITH EARLY ALZHEIMER'S DISEASE: TANGO PHASE 2 STUDY DESIGN
Author(s) -
Ratti Elena,
Sperling Bjoern,
Olsson Tina,
Zhang Li,
Muralidharan Kumar Kandadi,
Kong Jessica,
O'Gorman John,
Rajagovindan Raj,
Graham Danielle,
Griffin Sue,
Grundman Michael,
Jaeger Judith,
Henderson Chris,
Haeberlein Samantha Budd,
Ghosh Anirvan
Publication year - 2018
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.06.1388
Subject(s) - clinical dementia rating , placebo , medicine , adverse effect , progressive supranuclear palsy , clinical endpoint , dementia , surrogate endpoint , randomized controlled trial , disease , pathology , alternative medicine
baseline MMSE variability and the association of pre-intervention MMSE variability with ADAS-Cog change at 52 weeks in the entire trial cohort, collapsed across treatment assignment. Results:Change on the MMSE from screening to baseline was assessed in 373 participants. On average, participants were 71.9 (SD1⁄47.9) years old; had completed 15.1 (SD1⁄43.0) years of education; and scored 18.1 (SD1⁄43.0) on the MMSE at screening. Average change on the MMSE from screening to baseline was -0.21 (SD1⁄42.60) points. Change scores were normally distributed around the mean, as shown in Figure 1; however, there were outliers, with some participant’s scores changing as much as 10-12 points. To evaluate whether pre-randomization cognitive variability was associated with study outcome, participants were divided into quartiles based on their screening-to-baseline MMSE change score. Quartiles of pre-randomization variability did not differ in change on the ADAS-Cog at 52 weeks (Figure 2; F(3,338)1⁄41.49; p1⁄40.22). Conclusions:In this trial cohort of mildto-moderate AD participants, variability in MMSE score from screening to baseline was normally distributed around a small mean change of -0.21 points. Pre-randomization variability was not associated with ADAS-Cog change at 52 weeks. These results suggest that potential trial participants need not be excluded from participation based upon pre-randomization variability on mental-status screening.