Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

Novartis

Status and phase: Completed; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: Rivastigmine 15 cm^2; Drug: Placebo to 15 cm^2 patch; Drug: Placebo to 10 cm^2 patch; Drug: Rivastigmine 10 cm^2; Drug: Rivastigmine 5 cm^2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506415

CENA713D2340

Details and patient eligibility

About

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.

Enrollment: 1,584 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,584 participants in 4 patient groups

Open label: Rivastigmine (5 cm^2 / 10 cm^2)

Experimental group

Description:

Rivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48.

Treatment:

Drug: Rivastigmine 5 cm^2

Drug: Rivastigmine 10 cm^2

Double blind: Rivastigmine (10 cm^2)

Experimental group

Description:

Rivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period.

Treatment:

Drug: Placebo to 15 cm^2 patch

Drug: Rivastigmine 10 cm^2

Double blind: Rivastigmine (15 cm^2)

Experimental group

Description:

Rivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period.

Treatment:

Drug: Rivastigmine 15 cm^2

Drug: Placebo to 10 cm^2 patch

Extended open label Rivastigmine (10 cm^2)

Experimental group

Description:

Rivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Treatment:

Drug: Rivastigmine 10 cm^2