This database contains 168 studies, archived under the term: "adverse effects"
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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
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 […]
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 […]
High-intensity physical activity modulates diet effects on cerebrospinal amyloid-β levels in normal aging and mild cognitive impairment
Baker, Laura D.,
Bayer-Carter, Jennifer L.,
Skinner, Jeannine,
Montine, Thomas J.,
Cholerton, Brenna A.,
Callaghan, Maureen,
Leverenz, James B.,
Walter, Brooke K.,
Tsai, Elaine,
Postupna, Nadia,
Lampe, Johanna,
Craft, Suzanne
We previously showed that amyloid-β 1-42 (Aβ(42)) levels in cerebrospinal fluid (CSF) were markedly altered in response to a 4-week dietary intervention in normal aging and mild cognitive impairment (MCI). Here, we re-examined the data to assess whether diet-induced effects on CSF Aβ(42) were modulated by high intensity physical activity (hi-PA). Normal older adults (n […]
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 […]
Improvement in delusions and hallucinations in patients with dementia with Lewy bodies upon administration of yokukansan, a traditional Japanese medicine
Iwasaki, Koh,
Kosaka, Kenji,
Mori, Hideo,
Okitsu, Reina,
Furukawa, Katsutoshi,
Manabe, Yuta,
Yoshita, Mitsuhiro,
Kanamori, Aya,
Ito, Nobuo,
Wada, Kenji,
Kitayama, Michio,
Horiguchi, Jun,
Yamaguchi, Shuhei,
Takayama, Shin,
Fukuhara, Ryuji,
Ouma, Shinji,
Nakano, Seigo,
Hashimoto, Mamoru,
Kinoshita, Toru
Background: This multicentre open-label trial examined the efficacy and safety of the traditional Japanese medicine, or Kampo medicine, yokukansan (YKS), for behavioural and psychological symptoms of dementia (BPSD) in patients with dementia with Lewy bodies.; Methods: Sixty-three dementia with Lewy bodies patients with probable BPSD (M:W, 30:33; mean age, 78.2±5.8 years) were enrolled and treated […]
The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington’s disease
Barker, Roger A,
Mason, Sarah L.,
Harrower, Timothy P.,
Swain, Rachel A.,
Ho, Aileen K.,
Sahakian, Barbara J.,
Mathur, Raj,
Elneil, Sohier,
Thornton, Steven,
Hurrelbrink, Carrie,
Armstrong, Richard J.,
Tyers, Pam,
Smith, Emma,
Carpenter, Adrian,
Piccini, Paola,
Tai, Yen F.,
Brooks, David J.,
Pavese, Nicola,
Watts, Colin,
Pickard, John D.,
Rosser, Anne E.,
Dunnett, Stephen B.
Huntington’s disease (HD) is a fatal autosomal dominant neurodegenerative disease involving progressive motor, cognitive and behavioural decline, leading to death approximately 20 years after motor onset. The disease is characterised pathologically by an early and progressive striatal neuronal cell loss and atrophy, which has provided the rationale for first clinical trials of neural repair using […]
Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial
Campbell, Noll L.,
Dexter, Paul,
Perkins, Anthony J.,
Gao, Sujuan,
Li, Lang,
Skaar, Todd C.,
Frame, Amie,
Hendrie, Hugh C.,
Callahan, Chris M.,
Boustani, Malaz A.
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: […]