This database contains 30 studies, archived under the term: "tolerability"
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Rivastigmine for mild cognitive impairment in Parkinson disease: a placebo-controlled study
Mild cognitive impairment (MCI) in Parkinson’s disease (PD) may be associated with subtle functional impairment and worse quality of life. The objective of this study was to determine the efficacy and tolerability of rivastigmine for PD-MCI. Patients with PD-MCI (n = 28) were enrolled in a 24-week, randomized, double-blind, placebo-controlled, crossover, single-site study of the rivastigmine transdermal […]
Comparison of pharmacokinetics, pharmacodynamics, safety, and tolerability of the amyloid β monoclonal antibody solanezumab in Japanese and white patients with mild to moderate alzheimer disease
Uenaka, Kazunori,
Nakano, Masako,
Willis, Brian A.,
Friedrich, Stuart,
Ferguson-Sells, Lisa,
Dean, Robert A.,
Ieiri, Ichiro,
Siemers, Eric R.
Objectives: Solanezumab is a humanized anti-amyloid β monoclonal antibody being developed as a passive immunization treatment to slow the progression of Alzheimer disease (AD). Pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after a single dose of solanezumab were compared between Japanese and white patients with AD.; Methods: Japanese and white patients with mild to moderate AD […]
Pilot study of granulocyte-colony stimulating factor for treatment of Alzheimer’s disease
Sanchez-Ramos, Juan,
Cimino, Cynthia,
Avila, Ross,
Rowe, Amanda,
Chen, Ren,
Whelan, Glenn,
Lin, Xiaoyang,
Cao, Chuanhai,
Ashok, Raj
Human granulocyte colony-stimulating-factor (G-CSF) is widely used for treatment of neutropenia and to mobilize stem/progenitor cells for bone marrow transplantation. In studies of thousands of healthy donor subjects treated with G-CSF to mobilize stem/progenitor cells, the side-effect profile has been reported to be mild and reversible. In pre-clinical studies, G-CSF was reported to improve spatial […]
A placebo-controlled, multiple ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of avagacestat (BMS-708163) in healthy young and elderly subjects
Dockens, Randy,
Wang, Jun-Sheng,
Castaneda, Lorna,
Sverdlov, Oleksandr,
Huang, Shu-Pang,
Slemmon, Randy,
Gu, Huidong,
Wong, Oi,
Li, Hewei,
Berman, Robert M.,
Smith, Christina,
Albright, Charles F.,
Tong, Gary
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 […]
Apolipoprotein E genotype-specific short-term cognitive benefits of treatment with the antihypertensive nilvadipine in Alzheimer’s patients–an open-label trial
Kennelly, Sean,
Abdullah, Laila,
Kenny, Rose Anne,
Mathura, Venkat,
Luis, Cheryl A.,
Mouzon, Benoit,
Crawford, Fiona,
Mullan, Michael,
Lawlor, Brian
Background: Evidence suggests that dihydropyridine calcium channel blockers may be useful in preventing and treating Alzheimer’s disease (AD).; Objective: In an open-label trial of safety and tolerability of nilvadipine in patients with AD, we examined cognition and executive function over a short time period to determine an influence of nilvadipine on these outcomes.; Method: We […]
A randomized, double-blind, placebo-controlled trial of pridopidine in Huntington’s disease
We examined the effects of 3 dosages of pridopidine, a dopamine-stabilizing compound, on motor function and other features of Huntington’s disease, with additional evaluation of its safety and tolerability. This was a randomized, double-blind, placebo-controlled trial in outpatient neurology clinics at 27 sites in the United States and Canada. Two hundred twenty-seven subjects enrolled from […]
Safety and biomarker effects of solanezumab in patients with Alzheimer’s disease
Farlow, Martin,
Arnold, Steven E.,
van Dyck, Christopher H.,
Aisen, Paul S,
Snider, B. Joy,
Porsteinsson, Anton P.,
Friedrich, Stuart,
Dean, Robert A.,
Gonzales, Celedon,
Sethuraman, Gopalan,
Demattos, Ronald B.,
Mohs, Richard,
Paul, Steven M.,
Siemers, Eric R.
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 […]