Phase 3
Completed N=1,584
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
Source: ClinicalTrials.gov NCT00506415 ↗Enrolled (actual)
1,584
Serious AEs
14.4%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period — 4.9; 4.1 units on a scale
Summary
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period |
4.9; 4.1 | — |
| PRIMARY Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period |
-6.2; -4.4 | — |
| SECONDARY Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period |
90; 91 | — |
| SECONDARY Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period |
18.2; 16.3 | — |
| SECONDARY Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period |
9.3; 5.8 | — |
| SECONDARY Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period |
0.9; 1.4 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events |
1135; 193; 210; 263 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease,
- Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,
- A primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
- For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.
Exclusion Criteria
- Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
- Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,
- A diagnosis of probable or possible vascular dementia,
- A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
- A history or current diagnosis of cerebrovascular disease (e.g. stroke),
- A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00506415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.