NCT00623103

A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

Completed Phase 3 Results posted Last updated 19 October 2011

What this trial tests

Phase 3 trial testing Rivastigmine capsule in Parkinson's Disease Dementia in 583 participants. Completed.

Timeline

1 January 2008

Primary endpoint
1 November 2010

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	583
Start date	1 January 2008
Primary completion	1 November 2010
Sites	127 locations across United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany

Drugs / interventions tested

• Rivastigmine capsule
• Rivastigmine transdermal patch — full drug profile →

Conditions studied

• Parkinson's Disease Dementia — all drugs for Parkinson's Disease Dementia →

Sponsor

Novartis — full company profile →

Who can join

Adults 50 to 85, any sex, with Parkinson's Disease Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
  Time frame: 76 Weeks
  The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.
• Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
  Time frame: 76 Weeks
  The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of cognitive, psychiatric, and affective disorders associated with Parkinson's disease.
   Connolly B, Fox SH. · · 2014 · cited 51× · PMID 24288035 · DOI 10.1007/s13311-013-0238-x
2. Race and Ethnicity in Lewy Body Dementia: A Narrative Review.
   Bayram E, Holden SK, Fullard M, Armstrong MJ, et al · · 2023 · cited 20× · PMID 37355902 · DOI 10.3233/jad-230207
3. Rivastigmine from capsules to patch: therapeutic advances in the management of Alzheimer's disease and Parkinson's disease dementia.
   Sadowsky CH, Micca JL, Grossberg GT, Velting DM. · · 2014 · cited 19× · PMID 25667813 · DOI 10.4088/pcc.14r01654
4. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125