Objective: To study the safety and efficacy of a cholinesterase inhibitor, do nepezil hydrochloride, for the treatment of dementia in Parkinson’ s disease (P D). Methods: This was a randomised double blind, placebo c...Objective: To study the safety and efficacy of a cholinesterase inhibitor, do nepezil hydrochloride, for the treatment of dementia in Parkinson’ s disease (P D). Methods: This was a randomised double blind, placebo controlled, crossover s tudy in 22 subjects with PD and dementia. Participants were randomised to receiv e either donepezil followed by identical placebo, or placebo followed by donepezil. Do nepezil was administered at 5- 10 mg/day. Treatment periods were 10 weeks with a washout period of 6 weeks between the two periods. The primary outcome measure was the Alzheimer’ s Disease Assessment Scale Cognitive Subscale (ADAScog). Re sults: Donepezil was well tolerated and most adverse events were mild. There was no worsening of PD symptoms as measured by the total or motor sections of the U nified Parkinson’ s Disease Rating Scale. There was a 1.9 point trend toward be tter scores on the ADAScog on treatment compared with placebo that was not stati stically significant. The secondary cognitive measures showed a statistically si gnificant 2 point benefit on the Mini Mental Status Examination and no change on the Mattis Dementia Rating Scale (MDRS). The Clinical Global Impression of Chan ge (CGI) showed a significant 0.37 point improvement on donepezil. No improvemen t was observed on the MDRS or the Brief Psychiatric Rating Scale. Carryover betw een treatment periods was observed but was not statistically significant. Conclu sions: Donepezil was well tolerated and did not worsen PD. There may be a modest benefit on aspects of cognitive function. The possible clinical benefit measure d by CGI was reflected in only one of the cognitive scales used in this study.展开更多
文摘Objective: To study the safety and efficacy of a cholinesterase inhibitor, do nepezil hydrochloride, for the treatment of dementia in Parkinson’ s disease (P D). Methods: This was a randomised double blind, placebo controlled, crossover s tudy in 22 subjects with PD and dementia. Participants were randomised to receiv e either donepezil followed by identical placebo, or placebo followed by donepezil. Do nepezil was administered at 5- 10 mg/day. Treatment periods were 10 weeks with a washout period of 6 weeks between the two periods. The primary outcome measure was the Alzheimer’ s Disease Assessment Scale Cognitive Subscale (ADAScog). Re sults: Donepezil was well tolerated and most adverse events were mild. There was no worsening of PD symptoms as measured by the total or motor sections of the U nified Parkinson’ s Disease Rating Scale. There was a 1.9 point trend toward be tter scores on the ADAScog on treatment compared with placebo that was not stati stically significant. The secondary cognitive measures showed a statistically si gnificant 2 point benefit on the Mini Mental Status Examination and no change on the Mattis Dementia Rating Scale (MDRS). The Clinical Global Impression of Chan ge (CGI) showed a significant 0.37 point improvement on donepezil. No improvemen t was observed on the MDRS or the Brief Psychiatric Rating Scale. Carryover betw een treatment periods was observed but was not statistically significant. Conclu sions: Donepezil was well tolerated and did not worsen PD. There may be a modest benefit on aspects of cognitive function. The possible clinical benefit measure d by CGI was reflected in only one of the cognitive scales used in this study.
