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P3–285: Validation of a novel cognitive composite assessment for mild and prodromal Alzheimer's disease
Author(s) -
Harrison John,
Dgetluck Nancy,
Gawryl Maria,
Moebius Hans,
Hilt Dana
Publication year - 2013
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.2013.05.1359
Subject(s) - cronbach's alpha , cognition , recall , reliability (semiconductor) , psychology , episodic memory , cognitive test , audiology , internal consistency , placebo , medicine , clinical psychology , psychometrics , psychiatry , cognitive psychology , pathology , power (physics) , physics , alternative medicine , quantum mechanics
PBO and 20 hours post-dose for MOX at the time points of pharmacokinetic sample collection. Standard safety monitoring was conducted throughout the study. Plasma EVP-6124 and metabolite concentrations were determined with a validated assay. Effects of EVP-6124 and MOX on ECG were assessed by central tendency (PBOand baseline-adjusted individual-corrected QT derived from triplicate means; QTcI), categorical, and morphologic analyses. Results: EVP-6124 was well-tolerated and 52 subjects completed the study. The majority of treatment-emergent adverse events were mild in severity and no apparent trends or clinically meaningful changes were observed from baseline in clinical laboratory tests results or vital signs measurements. MOX caused a QT prolongation with the lower bound of the one-sided 95%CI for QTcI change above 5 ms, thereby validating the study design and conduct. The maximum upper bound of the one-sided 95% CI for EVP-6124 change in QTcI was 3.4 ms. Similar results were observed with QTcF analysis. No EVP-6124 effect on categorical or morphologic analyses was observed. No relationship between EVP-6124 or metabolite exposure and QTcI change was observed. Conclusions: EVP-6124 was well-tolerated and did not delay cardiac repolarization in healthy subjects at supratherapeutic exposures.