Importance: Early identification of Alzheimer disease (AD) is important for clinical management and affords the opportunity to assess potential disease-modifying agents in clinical trials. To our knowledge, this is the first report of a randomized trial to prospectively enrich a study population with prodromal AD (PDAD) defined by cerebrospinal fluid (CSF) biomarker criteria and mild […]
Background: Epidemiologic studies have identified several demographic factors, including gender, that may influence the progression from mild cognitive impairment (MCI) to Alzheimer’s disease (AD).; Objective: This analysis aimed to develop a sensitive model for detecting treatment benefits in patients with MCI by controlling for factors that predict progression to AD. The study used this statistical […]
Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% […]
Background: Bapineuzumab, a humanized anti-amyloid-beta monoclonal antibody, is in clinical development for the treatment of Alzheimer’s disease.; Methods: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials involving patients with mild-to-moderate Alzheimer’s disease–one involving 1121 carriers of the apolipoprotein E (APOE) ε4 allele and the other involving 1331 noncarriers. Bapineuzumab or placebo, with doses varying […]
Objective: The Relevant Outcome Scale for Alzheimer’s disease (ROSA) is a novel, valid, and reliable instrument for multidimensional assessment of Alzheimer’s disease (AD) symptoms across all severity stages. The ROSA and four standard instruments — the Alzheimer’s disease Assessment Scale-cognitive (ADAS-cog), Severe Impairment Battery (SIB), Disability Assessment for Dementia (DAD), and the Neuropsychiatric Inventory (NPI) […]