This database contains 68 studies, archived under the term: "adverse"
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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 […]
Safety and pharmacology of ponezumab (PF-04360365) after a single 10-minute intravenous infusion in subjects with mild to moderate Alzheimer disease
Burstein, Aaron H,
Zhao, Qinying,
Ross, Joel,
Styren, Scot,
Landen, Jaren W.,
Ma, Wendy W.,
McCush, Fred,
Alvey, Christine,
Kupiec, James W.,
Bednar, Martin M.
Objective: Ponezumab (PF-04360365) is a humanized anti-amyloid beta (Aβ) monoclonal antibody designed for treatment of Alzheimer disease (AD). A single 2-hour intravenous infusion of 0.1 to 10 mg/kg was previously shown to be safe and well tolerated in subjects with mild to moderate AD, with measurable effects on plasma and cerebrospinal fluid Aβ. This phase […]
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 […]
Efficacy and safety of donepezil 23 mg versus donepezil 10 mg for moderate-to-severe Alzheimer’s disease: a subgroup analysis in patients already taking or not taking concomitant memantine
Doody, Rachelle S.,
Geldmacher, David S.,
Farlow, Martin R.,
Sun, Yijun,
Moline, Margaret,
Mackell, Joan
Background/aims: A large multicenter trial of donepezil 23 mg/day versus donepezil 10 mg/day for moderate-to-severe Alzheimer’s disease allowed patients taking concomitant memantine. We evaluated the efficacy/safety of donepezil 23 and 10 mg/day in this trial, with respect to concomitant memantine use.; Methods: Prespecified analysis of data from a 24-week, randomized, double-blind trial. Patients were randomized […]
Ginkgo biloba extract EGb 761® in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg
Herrschaft, Horst,
Nacu, Anatol,
Likhachev, Sergey,
Sholomov, Ilya,
Hoerr, Robert,
Schlaefke, Sandra
A multi-centre, double-blind, randomised, placebo-controlled, 24-week trial with 410 outpatients was conducted to demonstrate efficacy and safety of a 240 mg once-daily formulation of Ginkgo biloba extract EGb 761(®) in patients with mild to moderate dementia (Alzheimer’s disease or vascular dementia) associated with neuropsychiatric symptoms. Patients scored 9 to 23 on the SKT cognitive battery, […]
Randomized, double-blind, parallel-group, 48-week study for efficacy and safety of a higher-dose rivastigmine patch (15 vs. 10 cm²) in Alzheimer’s disease
Cummings, Jeffrey,
Froelich, Lutz,
Black, Sandra E.,
Bakchine, Serge,
Bellelli, Giuseppe,
Molinuevo, José L.,
Kressig, Reto W.,
Downs, Pamela,
Caputo, Angelika,
Strohmaier, Christine
Aim: Determine whether patients with Alzheimer’s disease demonstrating functional and cognitive decline, following 24-48 weeks of open-label treatment with 9.5 mg/24 h (10 cm(2)) rivastigmine patch, benefit from a dose increase in a double-blind (DB) comparative trial of two patch doses.; Methods: Patients meeting prespecified decline criteria were randomized to receive 9.5 or 13.3 mg/24 […]
Safety, tolerability, and antibody response of active Aβ immunotherapy with CAD106 in patients with Alzheimer’s disease: randomised, double-blind, placebo-controlled, first-in-human study
Winblad, Bengt,
Andreasen, Niels,
Minthon, Lennart,
Floesser, Annette,
Imbert, Georges,
Dumortier, Thomas,
Maguire, R. Paul,
Blennow, Kaj,
Lundmark, Joens,
Staufenbiel, Matthias,
Orgogozo, Jean-Marc,
Graf, Ana
Background: Immunotherapy targeting the amyloid β (Aβ) peptide is a potential strategy to slow the progression of Alzheimer’s disease. We aimed to assess the safety and tolerability of CAD106, a novel active Aβ immunotherapy for patients with Alzheimer’s disease, designed to induce N-terminal Aβ-specific antibodies without an Aβ-specific T-cell response.; Methods: We did a phase […]
Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD
Egan, Michael,
Yaari, Roy,
Liu, Lian,
Ryan, Michael,
Peng, Yahong,
Lines, Christopher,
Michelson, David
We performed a clinical trial to evaluate the effects of the histamine subtype-3 receptor inverse agonist MK- 0249 on cognition in AD patients. Mild-to-moderate AD patients were randomized 1:1 to 4 weeks of double-blind daily treatment with oral MK-0249 5-mg or placebo. Pharmacokinetic and PET data suggested that MK-0249 5-mg daily would achieve approximately 85% […]