Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
CARE
A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.
1 other identifier
interventional
380
5 countries
40
Brief Summary
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2008
Typical duration for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 28, 2017
March 1, 2017
3.3 years
August 5, 2008
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
At week 24
Secondary Outcomes (2)
Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).
At baseline, wk 12 and wk 24
Patient compliance (drug accounting)
During 24 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
- MMSE score of ≥10 and ≤ 26;
You may not qualify if:
- Bradycardia (beats per minute less than 50)
- Body weight less than 40 kg;
- Hypersensitivity to cholinesterase inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Novartis Investigative Site
East Gosford, New South Wales, 2250, Australia
Novartis Investigative Site
Gosford, New South Wales, 2250, Australia
Novartis Investigative Site
Hornsby, New South Wales, 2077, Australia
Novartis Investigative Site
Randwick, New South Wales, 2031, Australia
Novartis Investigative Site
Chemside, Queensland, 4032, Australia
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
Woodville, South Australia, 5011, Australia
Novartis Investigative Site
Ballarat, Victoria, 3353, Australia
Novartis Investigative Site
Fitzroy, Victoria, 3065, Australia
Novartis Investigative Site
Heidelberg, Victoria, 3081, Australia
Novartis Investigative Site
Nedlands, WA 6009, Australia
Novartis Investigative Site
Johor Bahru, Johor, 81100, Malaysia
Novartis Investigative Site
Seremban, Negeri Sembilan, 70300, Malaysia
Novartis Investigative Site
Ipoh, Perak, 30990, Malaysia
Novartis Investigative Site
Kuala Lumpur, Selangor, 50586, Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
Seoul, Korea, 110 744, South Korea
Novartis Investigative Site
Bundang, Seongnam, 463-707, South Korea
Novartis Investigative Site
Seoul, 143-729, South Korea
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand
Novartis Investigative Site
Ankara, Turkey, 06100, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, 06500, Turkey (Türkiye)
Novartis Investigative Site
Bursa, Turkey, 16059, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey, 35040, Turkey (Türkiye)
Novartis Investigative Site
Konya, Turkey, 42080, Turkey (Türkiye)
Novartis Investigative Site
Altunizade, 34662, Turkey (Türkiye)
Novartis Investigative Site
Antalya, 07070, Turkey (Türkiye)
Novartis Investigative Site
Atakum / Samsun, 55139, Turkey (Türkiye)
Novartis Investigative Site
Emek / Ankara, 06510, Turkey (Türkiye)
Novartis Investigative Site
Etlik / Ankara, 06018, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, 34093, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, 34303, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35340, Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, 41380, Turkey (Türkiye)
Novartis Investigative Site
Mersin, 33079, Turkey (Türkiye)
Novartis Investigative Site
Meselik / Eskisehir, 26480, Turkey (Türkiye)
Novartis Investigative Site
Talas / Kayseri, 38039, Turkey (Türkiye)
Novartis Investigative Site
Uskudar / Istanbul, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 28, 2017
Record last verified: 2017-03