Phase 3
Completed N=859
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00423085 ↗Enrolled (actual)
859
Serious AEs
8.5%
Results posted
May 2011
Primary outcomePrimary: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) — 24.8; 25.2; 25.0; 26.1 units on a scale
Summary
The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE [Mini Mental State Examination] 10-20). A 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimer's Disease (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) |
24.8; 25.2; 25.0; 26.1; 25.7; 25.1 | — |
| PRIMARY Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J) |
0; 0; 0; 5; 12; 6 | — |
| SECONDARY Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD) |
66.70; 64.19; 64.15; 62.54; 61.19; 62.27 | — |
| SECONDARY Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) |
4.8; 4.7; 5.4; 4.8; 4.6; 5.1 | — |
| SECONDARY Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS) |
23.2; 24.3; 24.6; 26.1; 26.5; 26.2 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) |
16.7; 16.9; 16.4; 16.4; 16.6; 16.4 | — |
| SECONDARY Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE) |
16.6; 14.9; -1.7 | — |
| SECONDARY Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD) |
61.99; 51.95; -10.04 | — |
| SECONDARY Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale |
20.0; 24.0; 4.0 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
- A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
- An MMSE score of > or = 10 and 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Extension Phase Eligibility Criteria
Inclusion Criteria
- Patients who have completed the Double-blind Treatment Phase on study medication
Exclusion Criteria
- Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase
Data sourced from ClinicalTrials.gov (NCT00423085). 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.