Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

NCT00549601 | Completed Phase 4 Results

• 1 other identifier: CENA713DES07
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's; rivastigmine; transdermal; safety; randomized; switch; patch

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study

  Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).

  Baseline to end of study (Month 3)

Secondary Outcomes (5)

• Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)

  Baseline to end of study (Month 3)

• Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.

  Baseline to end of study (Month 3)

• Overall Caregiver Satisfaction With Treatment

  At end of study (Month 3)

• Overall Patient Satisfaction With Treatment

  At end of study (Month 3)

• Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3

  Baseline to Month 1 and Month 3

Study Arms (3)

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

EXPERIMENTAL

Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

Rivastigmine patch (9.5 mg/day)

EXPERIMENTAL

Drug: Rivastigmine patch (9.5 mg/day)

Rivastigmine capsules (6 mg to 12 mg/day)

ACTIVE COMPARATOR

Drug: Rivastigmine capsules (6 mg to 12 mg/day)

Interventions

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) DRUG

Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

Rivastigmine patch (9.5 mg/day) DRUG

Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).

Rivastigmine patch (9.5 mg/day)

Rivastigmine capsules (6 mg to 12 mg/day) DRUG

Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.

Rivastigmine capsules (6 mg to 12 mg/day)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score \> 10 and \< 26
• Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study
• Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
• Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.

You may not qualify if:

• A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
• Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
• History of allergy to topical products containing vitamin E
• Taken any of the following substances prior to randomization:
• succinylcholine-type muscle relaxants during the previous 2 weeks
• an investigational drug during the previous 4 weeks

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Barcelona, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals, MD

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 24, 2011
• Results First Posted: March 24, 2011

Record last verified: 2011-02

Locations

ES (1)