Objectives: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of 12 weekly infusions of solanezumab, an anti-β-amyloid (Aβ) antibody, in patients with mild-to-moderate Alzheimer’s disease. Cognitive measures were also obtained.; Methods: In this phase 2, randomized, double-blind, placebo-controlled clinical trial, 52 patients with Alzheimer’s disease received placebo or antibody (100 mg every 4 weeks, 100 […]
Background: Donepezil 23 mg/d, recently approved in the United States for treatment of moderate to severe Alzheimer’s disease (AD), was developed to address the need for an additional treatment option for patients with advanced AD. This report, based on a pivotal phase 3 study, presents a detailed analysis of the safety and tolerability of increasing […]
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 […]
Background: Treatment of Alzheimer’s disease with acetylcholinesterase inhibitors can result in symptomatic benefits, but patients often show variable responses. The objective of this post hoc analysis was to investigate relationships between easily identifiable baseline characteristics/demographics and cognitive response in patients treated with either donepezil 23 mg/d or 10 mg/d and to identify factors potentially influencing response.; Methods: […]
Background: Alzheimer’s disease is characterized by the presence of cortical amyloid-beta (Aβ) protein plaques, which result from the sequential action of β-secretase and γ-secretase on amyloid precursor protein. Semagacestat is a small-molecule γ-secretase inhibitor that was developed as a potential treatment for Alzheimer’s disease.; Methods: We conducted a double-blind, placebo-controlled trial in which 1537 patients […]
Background: Three small trials suggest that intravenous immunoglobulin can affect biomarkers and symptoms of mild-to-moderate Alzheimer’s disease. We tested the safety, effective dose, and infusion interval of intravenous immunoglobulin in such patients.; Methods: We did a multicentre, placebo-controlled phase 2 trial at seven sites in the USA and five in Germany. Participants with probable Alzheimer’s […]