Clinical trial NCT00423085: Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Official title: A 24-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: rivastigmine，Alzheimer's Disease, transdermal patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2007-01-17
Enrollment: 859
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm\^2 and rivastigmine 10 cm\^2) in a ratio of 1:1:1. During the Double-blind treatment phase, patients entered a 16-week Titration Period followed by an 8-week Maintenance Period. During the open-label extension phase, all patients started treatment with a 2.5 cm\^2 patch and the dose was increased to 10 cm\^2 over a 16-week titration period, followed by a maintenance period of 36 weeks.

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 \< or = 20

Exclusion Criteria:

* A current DSM-IV diagnosis of major depression
* Taken rivastigmine in the past
* A score of \> 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

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
timeFrame: Baseline and Week 24
measure: 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)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)
timeFrame: Baseline and Week 24
measure: Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)
timeFrame: Baseline and Week 24
measure: Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline and Week 24
measure: Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)
timeFrame: Extension Phase Baseline and Week 52 of extension phase
measure: Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)
timeFrame: Extension Phase Baseline and Week 52 of extension phase
measure: Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale
timeFrame: Extension Phase Baseline and Week 52 of extension phase
Other outcomes:
Locations:
city: Hokkaido region
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: