Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

Novartis

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Rivastigmine transdermal patch; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423085

CENA713D1301

CENA713D1301E1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 859 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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859 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.

Treatment:

Drug: Placebo

rivastigmine 5 cm^2

Experimental group

Description:

During the 16-week titration period patients received daily rivastigmine 2.5 cm\^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm\^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm\^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.

Treatment:

Drug: Rivastigmine transdermal patch

Rivastigmine 10 cm^2

Experimental group

Description:

During the 16-week titration period patients received daily rivastigmine 2.5 cm\^2 patch for the first 4 weeks, rivastigmine 5 cm\^2 patch for the next 4 weeks, rivastigmine 7.5 cm\^2 patch for the next 4 weeks and then rivastigmine 10 cm\^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.

Treatment:

Drug: Rivastigmine transdermal patch