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

NCT00423085 | Completed Phase 3 Results

• 2 other identifiers: CENA713D1301CENA713D1301E1
• Study Type: interventional
• Target: 859
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alzheimer's Disease

Keywords

rivastigmine，Alzheimer's Disease, transdermal patch

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

  The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.

  Baseline and Week 24

• Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)

  The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following: 1. Markedly improved 2. Moderately improved 3. Minimally improved 4. Unchanged 5. Minimally worse 6. Moderately worse 7. Markedly worse

  Baseline and Week 24

Secondary Outcomes (7)

• Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)

  Baseline and Week 24

• Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)

  Baseline and Week 24

• Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)

  Baseline and Week 24

• Change From Baseline in Mini-Mental State Examination (MMSE)

  Baseline and Week 24

• Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)

  Extension Phase Baseline and Week 52 of extension phase

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

rivastigmine 5 cm^2

EXPERIMENTAL

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.

Drug: Rivastigmine transdermal patch

Rivastigmine 10 cm^2

EXPERIMENTAL

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.

Drug: Rivastigmine transdermal patch

Interventions

Rivastigmine transdermal patch DRUG

Rivastigmine transdermal patch was provided in the following sizes and doses: 2.5 cm\^2 (4.5 mg), 5 cm\^2 (9 mg), 7.5 cm\^2 (13.5 mg), and 10 cm\^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.

Rivastigmine 10 cm^2; rivastigmine 5 cm^2

Placebo DRUG

Placebo transdermal patch was provided in the following sizes: 2.5 cm\^2, 5 cm\^2, 7.5 cm\^2 and 10 cm\^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A current DSM-IV diagnosis of major depression
• Taken rivastigmine in the past
• Extension Phase Eligibility Criteria
• Patients who have completed the Double-blind Treatment Phase on study medication
• Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Novartis Investigative Site

Hokkaido Region, Hokkaido, Japan

Location

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 17, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 10, 2014
• Results First Posted: May 25, 2011

Record last verified: 2014-01

Locations

JP (1)