This database contains 19 studies, archived under the term: "safety"
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Long-term effects of rivastigmine capsules in patients with traumatic brain injury
Silver, Jonathan M.,
Koumaras, Barbara,
Meng, Xiangyi,
Potkin, Steven G.,
Reyes, Patricio F.,
Harvey, Philip D.,
Katz, Douglas I.,
Gunay, Ibrahim,
Arciniegas, David B.
Objective: To investigate the safety, tolerability and efficacy of rivastigmine capsules (3-12 mg/day) in a 26-week, multi-centre, open-label extension of a double-blind study.; Methods: Patients with traumatic brain injury (TBI) and persistent cognitive impairment who had received rivastigmine (3-6 mg/day) or placebo for 12 weeks could enter the extension study and receive rivastigmine (< or […]
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) […]
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 […]
EHT0202 in Alzheimer’s disease: a 3-month, randomized, placebo-controlled, double-blind study
Vellas, B.,
Sol, O.,
Snyder, P. J.,
Ousset, P. J.,
Haddad, R.,
Maurin, M.,
Lemarié, J. C.,
Désiré, L.,
Pando, M. P.
Background: EHT0202 (etazolate hydrochloride) is a new compound exhibiting both potential disease-modifying and symptomatic treatment properties in Alzheimer’s Disease increasing alpha-secretase activity and sAPP alpha secretion, as well as acting as a GABA-A receptor modulator and as a PDE-4 inhibitor.; Methods: This pilot, randomized, double-blind, placebo-controlled, parallel group, multicentre, Phase IIA study was conducted in […]
One-year safety and tolerability profile of pridopidine in patients with Huntington disease
Squitieri, Ferdinando,
Landwehrmeyer, Bernhard,
Reilmann, Ralf,
Rosser, Anne,
de Yebenes, Justo Garcia,
Prang, Allan,
Ivkovic, Jelena,
Bright, Jeremy,
Rembratt, Åsa
Objective: To assess the 1-year safety profile of the dopaminergic stabilizer pridopidine in patients with Huntington disease. Methods: Patients received pridopidine 45 mg/day for 4 weeks then pridopidine 90 mg/day for 22 weeks in this 6-month open-label extension (OLE) of the 6-month MermaiHD randomized controlled trial (RCT). Any adverse events (AEs) were recorded. Patients were […]
Navigation for people with mild dementia
Community dwelling is a problem for people with dementia. Can GPS route navigation support on a mobile device provide a solution? In a small scale exploratory research with this target group we studied the effects of two different types of audio instructions and assessed the pedestrian safety while operating the device. Methodological issues that limited […]
Oxytocin for frontotemporal dementia: A randomized dose-finding study of safety and tolerability
Finger, E. C.,
MacKinley, J.,
Blair, M.,
Oliver, L. D.,
Jesso, S.,
Tartaglia, M. C.,
Borrie, M.,
Wells, J.,
Dziobek, I.,
Pasternak, S.,
Mitchell, D. G. V.,
Rankin, K.,
Kertesz, A.,
Boxer, A.
Objective: To determine the safety and tolerability of 3 doses of intranasal oxytocin (Syntocinon; Novartis, Bern, Switzerland) administered to patients with frontotemporal dementia (FTD). Methods: We conducted a randomized, parallel-group, double-blind, placebo-controlled study using a dose-escalation design to test 3 clinically feasible doses of intranasal oxytocin (24, 48, or 72 IU) administered twice daily for […]
Comparing the efficacy and safety of Crocus sativus L. With memantine in patients with moderate to severe Alzheimer’s disease: A double‐blind randomized clinical trial
Farokhnia, Mehdi,
Shafiee Sabet, Mehdi,
Iranpour, Negar,
Gougol, Amirhossein,
Yekehtaz, Habibeh,
Alimardani, Roozbeh,
Farsad, Farzaneh,
Kamalipour, Maryam,
Akhondzadeh, Shahin
Objectives Limited pharmacological options are available for the management of Alzheimer’s disease (AD) in severe stages. Cognitive‐enhancing properties of saffron, the dried stigma of Crocus sativus L., have been evidenced in different studies. We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to […]
Treatment of Alzheimer’s disease with the GSK-3 inhibitor tideglusib: a pilot study
del Ser, Teodoro,
Steinwachs, Klaus C.,
Gertz, Hermann J.,
Andrés, María V.,
Gómez-Carrillo, Belén,
Medina, Miguel,
Vericat, Joan A.,
Redondo, Pilar,
Fleet, David,
Leon, Teresa
This pilot, double-blind, placebo-controlled, randomized, escalating dose trial explored the safety and efficacy of tideglusib, an inhibitor of glycogen synthase kinase-3, in Alzheimer’s disease (AD) patients. Thirty mild-moderate AD patients on cholinesterase inhibitor treatment were administered escalating doses (400, 600, 800, 1,000 mg) of tideglusib or placebo (ratio 2 : 1) for 4, 4, 6, […]