Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

Novartis

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Rivastigmine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529619

CENA713D1403

Details and patient eligibility

About

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

Enrollment: 52 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 = 23
• Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
• Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
• Inadequate compliance with the ChE inhibitors at screening and baseline
• Presence of caregiver's burden for administering drugs orally at screening and baseline
• Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
• Patients with swallowing difficulties at screening and baseline

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Rivastigmine 18 mg

Experimental group

Description:

During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg 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