Rivastigmine and Concomitant Memantine in Alzheimer's Disease: Safety and Tolerability

CNS Spectrums ◽  
2010 ◽  
Vol 15 (9) ◽  
pp. 594-598 ◽  
Author(s):  
Beth Safirstein ◽  
Xiangyi Meng ◽  
Jason T. Olin
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Safety Data ◽  
Gastrointestinal Symptoms ◽  
Application Site ◽  
Transdermal Patch ◽  
Open Label ◽  
Rivastigmine Patch ◽  
Multicenter Trials ◽  
Memantine Treatment

ABSTRACTBackground: Investigate the safety and tolerability of rivastigmine capsules and transdermal patch in patients with moderate Alzheimer's disease receiving concomitant memantine.Methods: Safety data from two prospective, open-label, multicenter trials were analyzed. Study US32: patients received rivastigmine capsules (3–12 mg/day) plus memantine (20 mg/day). Study US38: patients switched from donepezil to rivastigmine patches (4.6 mg/24 hours) immediately or following 7 days' withdrawal; ∼50% received concomitant memantine (20 mg/day).Results: The rivastigmine patch demonstrated more favorable tolerability than rivastigmine capsules, being associated with fewer adverse events (AEs) (73% versus 83%), serious AEs (10% versus 23%) and gastrointestinal symptoms (4% versus 26% for nausea; 4% versus 11% for vomiting). Application site reactions occurred in 17% of patients.Conclusion: Concomitant memantine treatment with rivastigmine patch and capsule is generally well tolerated. The favorable tolerability and safety profile of rivastigmine transdermal patch is not further improved with concomitant memantine. Recommendations to minimize application site reactions are provided.

scholarly journals Efficacy, Safety, and Tolerability of Switching from Oral Cholinesterase Inhibitors to Rivastigmine Transdermal Patch with 1-Step Titration in Patients with Mild to Moderate Alzheimer’s Disease: A 24-Week, Open-Label, Multicenter Study in Japan

2019 ◽  
Vol 9 (2) ◽  
pp. 302-318 ◽  
Author(s):  
Kengo Ueda ◽  
Sadao Katayama ◽  
Tetsuaki Arai ◽  
Nobuo Furuta ◽  
Shinichiro Ikebe ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Cholinesterase Inhibitors ◽  
Poor Response ◽  
Delivery Rate ◽  
Application Site ◽  
Transdermal Patch ◽  
Maintenance Period ◽  
Open Label ◽  
Titration Period

Background: Few studies have investigated treatment options for patients with Alzheimer’s disease (AD) showing a poor response to oral cholinesterase inhibitors (ChEIs) in Japan. Objective: To investigate the efficacy and safety of switching from oral ChEIs to rivastigmine transdermal patch in patients with AD. Methods: In this multicenter, open-label, phase IV study in outpatient clinics in Japan, patients with mild-moderate AD who had a poor response to or experienced difficulty in continuing donepezil or galantamine were switched to rivastigmine transdermal patch (5 cm2; loaded dose 9 mg, delivery rate 4.6 mg/24 h) with a 1-step titration in week 4 (10 cm2; loaded dose 18 mg, delivery rate 9.5 mg/24 h), which was continued for 4 weeks in the titration period and 16 weeks in a maintenance period. The primary endpoint was the change in Mini-Mental State Examination (MMSE) total score from baseline to week 24. Results: A total of 118 patients were enrolled and switched to rivastigmine, of which 102 completed the 24-week study. The MMSE total score was essentially unchanged during the study, with a least-square mean change (SD) of −0.35 (2.64) at week 24 (p = 0.1750). Exploratory analysis with a mixed-effect model comparing changes in MMSE between the pre- and post-switch periods suggested that switching to rivastigmine prevented a worsening of MMSE. Application site skin reactions/irritations occurred in 30.5% of patients overall, in 22.0% in the 8-week titration period, and in 10.2% in the 16-week maintenance period. Conclusion: Within-class switching from an oral ChEI to rivastigmine transdermal patch might be an efficacious and tolerable option for AD patients showing a poor or limited response to a prior oral ChEI.

scholarly journals Sustained Effects of Once-Daily Memantine Treatment on Cognition and Functional Communication Skills in Patients with Moderate to Severe Alzheimer's Disease: Results of a 16-Week Open-Label Trial

2011 ◽  
Vol 25 (3) ◽  
pp. 463-475 ◽  
Author(s):  
Jörg B. Schulz ◽  
Michael Rainer ◽  
Hans-Hermann Klünemann ◽  
Alexander Kurz ◽  
Stefanie Wolf ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Communication Skills ◽  
Functional Communication ◽  
Open Label ◽  
Once Daily ◽  
Memantine Treatment ◽  
Sustained Effects ◽  
Open Label Trial

The cost-utility of the rivastigmine transdermal patch in the management of patients with moderate Alzheimer's disease in the US

2009 ◽  
Vol 36 (S 02) ◽  
Author(s):  
A Brennan ◽  
B Nagy ◽  
A Brandtmüller ◽  
SK Thomas ◽  
M Gallagher ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Cost Utility ◽  
Transdermal Patch ◽  
The Us ◽  
The Cost

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

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