Conditions: Parkinson's Disease Dementia
Keywords: Parkinson's disease dementia cholinesterase inhibitor rivastigmine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 583
Healthy volunteers: no

Brief summary:
The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Detailed description:

Arms:
arm 1: Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76. arm 2: Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.

Interventions: intervention 1: Rivastigmine capsule intervention 2: Rivastigmine transdermal patch
Intervention descriptions: intervention 1: Rivastigmine capsules orally twice a day. Target dose 12 mg/day. intervention 2: Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.

Protocol document: