Tramiprosate in mild-to-moderate Alzheimer's disease - a randomized, double-blind, placebo-controlled, multi-centre study (the Alphase Study).

Adjusted models For all study outcomes, unanticipated and highly significant Site effects ( P < 0.001) were detected in the planned ANCOVA models.

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These adjusted models showed a trend toward a treatment effect for ADAS-cog (P = 0.098) and indicated significantly less HV loss for tramiprosate 100 mg (P = 0.035) and 150 mg (P = 0.009) compared to placebo.

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Additional covariates were selected using a four-step process: 1) identification of cross-sectional and longitudinal patterns in the data, 2) identification of variables which were predictors of outcome based on a statistical trend defined as a P < 0.15, 3) selection of variables that were significant independent predictors of outcome, with a P < 0.15 tolerance, and 4) assessment of the clinical relevance of the identified variables by an independent scientific advisory committee.

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