This database contains 57 studies, archived under the term: "adverse events"
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A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia
Mizukami, Katsuyoshi,
Asada, Takashi,
Kinoshita, Toru,
Tanaka, Katsuaki,
Sonohara, Kazuki,
Nakai, Ryuhei,
Yamaguchi, Kiyoshi,
Hanyu, Haruo,
Kanaya, Kiyoshi,
Takao, Tetsuya,
Okada, Masakatsu,
Kudo, Sumio,
Kotoku, Hayato,
Iwakiri, Masahiko,
Kurita, Hirofumi,
Miyamura, Toshihiro,
Kawasaki, Yosuke,
Omori, Koji,
Shiozaki, Kazumasa,
Odawara, Toshinari,
Suzuki, Tatsuya,
Yamada, Shizuru,
Nakamura, Youichi,
Toba, Kenji
The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer’s disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I […]
Safety and tolerability of the rivastigmine patch: results of a 28-week open-label extension
Grossberg, George,
Sadowsky, Carl,
Fröstl, Hans,
Frölich, Lutz,
Nagel, Jennifer,
Tekin, Sibel,
Zechner, Stefanie,
Ros, Jacqueline,
Orgogozo, Jean-Marc
The primary objective of the open-label extension was to evaluate the long-term safety and tolerability of a transdermal rivastigmine patch up to 1 year, as a novel approach to treatment in Alzheimer disease. This was a 28-week extension to a 24-week, double-blind, double-dummy, placebo-controlled, and active-controlled study evaluating rivastigmine patches [9.5 mg/24 h (10 cm2) […]
Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial
Doody, R. S.,
Ferris, S. H.,
Salloway, S.,
Sun, Y.,
Goldman, R.,
Watkins, W. E.,
Xu, Y.,
Murthy, A. K.
Background: Treatment of mild cognitive impairment (MCI) with cholinesterase inhibitors may improve symptoms.; Methods: In this multicenter, randomized, placebo-controlled trial, subjects with MCI entered a 3-week placebo run-in period followed by 48 weeks of double-blind donepezil (5 mg/day for 6 weeks, then 10 mg/day for 42 weeks) or placebo treatment. Primary efficacy variables included change […]
Randomized controlled trial of atomoxetine for cognitive dysfunction in early Huntington disease
Beglinger, Leigh J.,
Adams, Williams H.,
Paulson, Henry,
Fiedorowicz, Jess G.,
Langbehn, Douglas R.,
Duff, Kevin,
Leserman, Anne,
Paulsen, Jane S.
Background: Cognitive symptoms are associated with functional disability in Huntington disease; yet, few controlled trials have examined cognitive treatments that could improve patient independence and quality of life. Atomoxetine is a norepinephrine reuptake inhibitor approved for treatment of attention-deficit/hyperactivity disorder.; Methods: Twenty participants with mild Huntington disease who complained of inattention were randomized to receive […]
Long-term safety and efficacy of donepezil in patients with severe Alzheimer’s disease: results from a 52-week, open-label, multicenter, extension study in Japan
Homma, Akira,
Imai, Yukimichi,
Tago, Hisao,
Asada, Takashi,
Shigeta, Masahiro,
Iwamoto, Toshihiko,
Takita, Masashi,
Arimoto, Itaru,
Koma, Hiroshi,
Takase, Takao,
Ohbayashi, Toshio
Background/aims: A 6-month, randomized, double-blind, placebo-controlled study was extended to evaluate long-term safety and efficacy of donepezil in community-dwelling Japanese patients with severe Alzheimer’s disease (AD).; Methods: 189 patients were enrolled from the double-blind study into a 52-week, open-label extension study. After a 2- to 8-week washout, donepezil was escalated within 6 weeks to 10 […]
Safety and efficacy of galantamine (Reminyl) in severe Alzheimer’s disease (the SERAD study): a randomised, placebo-controlled, double-blind trial
Burns, Alistair,
Bernabei, Roberto,
Bullock, Roger,
Cruz Jentoft, Alfonso J.,
Frölich, Lutz,
Hock, Christoph,
Raivio, Minna,
Triau, Eric,
Vandewoude, Maurits,
Wimo, Anders,
Came, Elizabeth,
Van Baelen, Bart,
Hammond, Gerry L.,
van Oene, Joop C.,
Schwalen, Susanne
Background: The efficacy of galantamine has been shown in patients with mild, moderate, and advanced moderate Alzheimer’s disease (AD). Here we report its efficacy in patients with severe AD.; Methods: Between December, 2003, and March, 2007, patients aged 84 (SD 6) years with severe AD (mini-mental state examination [MMSE] score 5-12 points), in a nursing […]
Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study
Doody, Rachelle S.,
Ferris, Steven,
Salloway, Stephen,
Yijun, Sun,
Goldman, Robert,
Yikang, Xu,
Gao, Jeff,
Murthy, Anita K.
Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% […]
Safety/Tolerability and efficacy of rivastigmine in taiwanese patients with Alzheimer’s disease: a prospective post-marketing surveillance study
Chiu, Pai-Yi,
Dai, Dao-En,
Hsu, Hai-Pei,
Lee, Chao,
Lin, Juei-Jueng,
Kuo, Hung-Chou,
Huang, Ying-Chih,
Liu, Yung-Chang,
Tsai, Ching-Piao
Background and Objectives: Rivastigmine is approved for the symptomatic treatment of mild to moderate dementia in patients with Alzheimer’s disease. The drug was launched in Taiwan in 2000. The primary objective of this post-marketing surveillance (PMS) study was to describe the safety/tolerability of treatment with rivastigmine capsules in patients with Alzheimer’s disease. The secondary objectives […]