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This database contains 22 studies, archived under the term: "pharmacokinetics"

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A placebo-controlled, multiple ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of avagacestat (BMS-708163) in healthy young and elderly subjects
Background and Objectives: Avagacestat is an orally active γ-secretase inhibitor that selectively inhibits amyloid β (Aβ) synthesis in cell culture and animal models. The objective of the current study was to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of avagacestat over 28 days in healthy young men and elderly men and women […]

Longitudinal changes of fractional anisotropy in Alzheimer’s disease patients treated with galantamine: a 12-month randomized, placebo-controlled, double-blinded study
Diffusion tensor imaging (DTI) demonstrates decline of fractional anisotropy (FA) as a marker of fiber tract integrity in Alzheimer’s disease (AD). We aimed to assess the longitudinal course of white matter microstructural changes in AD and healthy elderly control (HC) subjects and to evaluate the effects of treatment with the cholinesterase inhibitor galantamine on white […]

Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial
Background: The class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer’s disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence.; Methods/design: […]

Safety and changes in plasma and cerebrospinal fluid amyloid beta after a single administration of an amyloid beta monoclonal antibody in subjects with Alzheimer disease
Objectives: Active and passive immunization strategies have been suggested as possible options for the treatment of Alzheimer disease (AD). LY2062430 (solanezumab) is a humanized monoclonal antibody being studied as a putative disease-modifying treatment of AD.; Methods: Patients with mild to moderate AD were screened and selected for inclusion. Initial screening was performed for 54 subjects, […]

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease
Objective: This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD).; Methods: A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the […]

Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer’s disease
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 […]

Association of 9-hydroxy risperidone concentrations with risk of switching or discontinuation in the clinical antipsychotic trial of intervention effectiveness-Alzheimer’s disease trial
Risperidone has been used to treat behavioral symptoms, such as delusions and agitation, in people with Alzheimer’s disease. The relationship between magnitude and variability of risperidone and 9-hydroxy risperidone exposure and the relationship with time to discontinuation of the medication were explored. Sixty-five subjects from the Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer’s Disease Trial that […]

Effect of CYP2D6*10 and APOE polymorphisms on the efficacy of donepezil in patients with Alzheimer’s disease
Background: The aim of this study was to evaluate the effect of CYP2D6*10 and APOE polymorphisms on both steady-state plasma concentrations (Cp) and clinical response of donepezil in patients with mild-to-moderate Alzheimer’s disease (AD).; Methods: A total of 110 Chinese AD patients participated in this study. Patients were treated with 5 to 10 mg of […]

Vitamin D and risk of cognitive decline in elderly persons
Background: To our knowledge, no prospective study has examined the association between vitamin D and cognitive decline or dementia.; Methods: We determined whether low levels of serum 25-hydroxyvitamin D (25[OH]D) were associated with an increased risk of substantial cognitive decline in the InCHIANTI population-based study conducted in Italy between 1998 and 2006 with follow-up assessments […]

A single ascending dose study of bapineuzumab in patients with Alzheimer disease
The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, were evaluated in patients with mild-to-moderate Alzheimer disease in a phase 1, randomized, third-party unblinded, placebo-controlled, single ascending dose trial. Thirty patients received bapineuzumab infusion of 0.5, 1.5, or 5 mg/kg or placebo (6 active, 2 placebo for 0.5 […]

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