Clinical assessments
semi‐structured
ADVERSE EFFECTS
The primary outcome measure was the Alzheimer's Disease Assessment Scale‐cognitive subscale (ADAS‐cog)The secondary outcome measurements included Clinician's Interview‐Based Impression of Change plus Caregiver Input (CIBIC‐plus)The CIBIC‐plus is a global assessment of change based on a comprehensive, semi‐structured interview that includes caregiver‐supplied information. It is a seven‐point rating scale ranging from 1 to 7, where one represents markedly improved; four represents no change; and seven represents markedly worse.The battery of additional cognitive tests included speed of processing (category fluency), working memory (Wechsler Memory Scale‐Third Edition, Spatial Span),Systemic adverse effects were evaluated every 8 weeks (at weeks 0, 8, 16, and 24) by physical and neurological examinations and laboratory tests including complete blood count (CBC) and biochemistry and reviewed by applying the Udvalg for Kliniske Undersogelser Side‐effects Rating Scale.Only raters who reached the intra‐class correlation coefficients of ≥0.90 during pre‐study training were allowed to rate the study patients. To maintain high inter‐rater reliability and to prevent rater drift, raters met at least once per quarter for training and reliability retesting. To minimize inter‐rater variability, each individual patient was assessed by the same raters throughout the trial.