Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

Browse trials for

• Parkinson Disease 4,487
• Dementia 2,172

Keywords

• Parkinson's disease dementia
• cholinesterase inhibitor
• rivastigmine

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 583 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Rivastigmine capsule

  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.

  Drug: Rivastigmine capsule

• Experimental
  Rivastigmine patch

  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.

  Drug: Rivastigmine transdermal patch

Interventions

• DrugRivastigmine capsule

  Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

  Also known as: Exelon®

• DrugRivastigmine transdermal patch

  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.

  Also known as: Exelon®

Primary outcomes

1. Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)

   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.

   Time frame: 76 Weeks

2. 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)

   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.

   Time frame: 76 Weeks

Secondary outcomes

1. Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

   Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.

   Time frame: From Baseline to Weeks 8, 16, 24, 52 and 76

2. Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline

   Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention \[0-37\], Initiation/Perservation \[0-37\] (performing alternating movements), Construction \[0-6\] (copying designs), Conceptualization \[0-39\] (similarities) and Memory \[0-25\] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.

   Time frame: From Baseline to Weeks 16, 24, 52 and 76

3. Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

   The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.

   Time frame: From Baseline to Weeks 16, 24, 52 and 76

4. Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

   The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).

   Time frame: At Week 16, 24, 52 and 76 (or early discontinuation)

5. Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

   The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items. The change from baseline was calculated such that a positive change indicates an improvement.

   Time frame: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)

6. UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)

   Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).

   Time frame: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)

Baseline characteristics