Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

NCT00561392 | Completed Phase 4 Results

• 1 other identifier: CENA713DDE15
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Rivastigmine; Patch

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study

  Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.

  Baseline to Week 24

• Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study

  Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.

  Baseline to Week 24

• Percentage of Participants Who Were Compliant to the 10 cm^2 Patch

  Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.

  Baseline to Week 24

Secondary Outcomes (6)

• Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24

  Baseline and Week 24

• Mean Change From Baseline in the Trail-making Test Part A Score at Week 24

  Baseline to Week 24

• Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24

  Baseline to Week 24

• Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician

  Baseline to Week 24

• Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver

  Baseline t0 Week 24

Study Arms (1)

Rivastigmine 5 and 10 cm^2 patch

EXPERIMENTAL

For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.

Drug: Rivastigmine 5 and 10 cm^2 patch

Interventions

Rivastigmine 5 and 10 cm^2 patch DRUG

Rivastigmine 5 and 10 cm^2 patch

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
• Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
• MMSE (Mini-Mental State Examination) score of \> 10 and \< 26
• Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
• Patients who failed to benefit from previous cholinesterase inhibitor treatment

You may not qualify if:

• Patients not treated according to the product monograph for rivastigmine capsules
• patients involved in a clinical trial
• 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)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Munich, Germany

Location

Related Publications (1)

• Articus K, Baier M, Tracik F, Kuhn F, Preuss UW, Kurz A. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6.

  PMID: 21645184 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 16, 2012
• Results First Posted: March 11, 2011

Record last verified: 2012-04

Locations

DE (1)