1. The Efficacy of Transdermal Rivastigmine in Mild to Moderate Alzheimer's Disease with Concomitant Small Vessel Cerebrovascular Disease: Findings from an Open-Label Study.
- Author
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Yatawara C, Zailan FZ, Chua EV, Lim LLH, Silva E, Wang JS, Ng A, Ng KP, and Kandiah N
- Subjects
- Administration, Cutaneous, Aged, Cognition drug effects, Female, Humans, Male, Neuroprotective Agents administration & dosage, Neuroprotective Agents adverse effects, Treatment Outcome, Activities of Daily Living, Alzheimer Disease complications, Alzheimer Disease diagnosis, Alzheimer Disease drug therapy, Alzheimer Disease psychology, Cerebral Small Vessel Diseases complications, Cerebral Small Vessel Diseases diagnosis, Rivastigmine administration & dosage, Rivastigmine adverse effects
- Abstract
Background: Rivastigmine is used to treat cognitive impairment in Alzheimer's disease (AD); however, the efficacy of Rivastigmine in patients with AD and concomitant small vessel cerebrovascular disease (svCVD) remains unclear. We investigated the effectiveness of Rivastigmine Patch in patients with AD and svCVD., Methods: In this open-label study, 100 patients with AD and MRI confirmed svCVD received 9.5mg/24 hours Rivastigmine transdermal treatment for 24 weeks. The primary outcome was global cognition indexed using the ADAS-Cog. Secondary outcomes included clinical-rated impression of change (indexed using (ADCS-CGIC), activities of daily living (indexed using ADCS-ADL) and side effects., Results: Overall, performance on the ADAS-Cog after 24 weeks deteriorated by 1.78 (SD = 5.29) points. Fifty-two percent of the sample demonstrated improvement or remained stable, while 48% demonstrated worsening of ADAS-Cog scores. Of the 52%, significant improvement (2 or more-point decline) on the ADAS-Cog was observed in 25% of the sample, with a mean change of -5.08 (SD = 3.11). A decline on the ADAS-Cog was observed in 48% of the sample, with a mean change of 6 (SD = 2.98) points. Cognitive outcome did not interact with severity of svCVD. ADCS-ADL scores remained stable from baseline to week 24 and ADCS-CGIC reports indicated that 81% of the patients remained stable after treatment. Side effects were reported by 16% of the patients, with contact dermatitis being the most common., Conclusion: Our findings suggest that Rivastigmine may have a role in the management of patients having AD and concomitant mild-severe svCVD, with minimal side effects., Competing Interests: Novartis (Singapore) Pte Ltd partially funded the study and the cost of the investigational product. Novartis did not have any role in the concept of the study, data analyses or writing of the manuscript. This was an investigator-initiated study wherein the study design, data collection, data analyses as well as writing of this manuscript was carried out by the study team at NNI with no involvement from Novartis. The principal investigator and study team members did not receive any honorarium or personal fees from Novartis for carrying out this study. However, Dr Nagaendran Kandiah received honorarium from Novartis for lectures not related to any aspect of this study. Dr Nagaendran Kandiah reports grants from Novartis Pharmaceuticals, during the conduct of the study; and received honoraria for speaker engagements and personal fees from Novartis Pharmaceuticals, and honoraria and grant support from Eisai Pharmaceuticals and Schwabe Pharmaceuticals, outside the submitted work. The authors report no other potential conflicts of interest for this work., (© 2021 Yatawara et al.)
- Published
- 2021
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