A Pilot Phase IV Open-Label Study Investigating the Safety and Tolerability of Donepezil 23mg Once Daily in Patients with Moderate to Severe AD Switched from Exelon Patch 9.5mg Daily - Abstract
Introduction: Since previous studies demonstrated the AD subjects treated with Donepezil23-mg showed a statistically significant improvement on cognition compared to AD subjects on 10mg daily, we evaluated the effects of treatment with donepezil23mg on moderate to severe AD when switched from rivastigmine patch 9.5mg daily using a titration schedule.
Methods: This was a 24-week, randomized, open label, study of the effect of switching from Exelon patch 9.5 mg to a regimen of Donepezil 23 mg daily in moderate to severe AD with a titration schedule. Subjects received the MMSE and Clinical Dementia Rating scale (CDR) at study entry and termination/completion. 26 individuals were recruited for this study (17 males (65.4%) and 9 females (34.6%). Mean age was 78.9 years (SD=9.35 years; Range 53-92 years).
Results: 31% (8/26= 30.8%) of participants completed the study. The mean baseline MMSE score for the entire group was 10.7 (SD=5.9; Median=11.5; Range=1-19) with no statistically significant difference (p=.778) between individuals who completed through Week 24 of the study (Mean=10.14 SD=5.4; Median=12.0; Range=1-16) and those who did not complete the study (Mean=10.89; SD= 6.15; Median=11.00; Range=1-19). The baseline CDR Sum of Boxes and CDR Global scores were also not found to be significantly different between completers and non-completers (p=.582 and p=.308 respectively). Adverse events included nausea (38.5%), vomiting (30.8%), diarrhoea (15.4%), hypersomnia (11.5%), dizziness and headache (7.7%).Introducing alternating doses of 10 mg and 23 mg donepizil improved tolerability.
Conclusions: Switching from rivastigmine patch 9.5mg to donepezil 23mg is a treatment option but this should be implemented with a titration schedule of alternating day 10mg/23mg to improve tolerability.