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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00731224




Registration number
NCT00731224
Ethics application status
Date submitted
5/08/2008
Date registered
8/08/2008
Date last updated
28/03/2017

Titles & IDs
Public title
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
Scientific title
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.
Secondary ID [1] 0 0
CENA713DAU01
Universal Trial Number (UTN)
Trial acronym
CARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivastigmine transdermal patch

Experimental: 1 -


Treatment: Drugs: Rivastigmine transdermal patch


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Timepoint [1] 0 0
At week 24
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
At baseline, wk 12 and wk 24
Secondary outcome [2] 0 0
Patient compliance (drug accounting)
Timepoint [2] 0 0
During 24 weeks

Eligibility
Key inclusion criteria
- 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;
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Bradycardia (beats per minute less than 50)

- Body weight less than 40 kg;

- Hypersensitivity to cholinesterase inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hornsby
Recruitment hospital [4] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [5] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [6] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [8] 0 0
Novartis Investigative Site - Ballarat
Recruitment hospital [9] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [10] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [11] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4032 - Chemside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3353 - Ballarat
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3081 - Heidelberg
Recruitment postcode(s) [11] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Korea
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seongnam
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Johor
Country [5] 0 0
Malaysia
State/province [5] 0 0
Negeri Sembilan
Country [6] 0 0
Malaysia
State/province [6] 0 0
Perak
Country [7] 0 0
Malaysia
State/province [7] 0 0
Selangor
Country [8] 0 0
Malaysia
State/province [8] 0 0
Kuala Lumpur
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok
Country [10] 0 0
Turkey
State/province [10] 0 0
Altunizade
Country [11] 0 0
Turkey
State/province [11] 0 0
Ankara
Country [12] 0 0
Turkey
State/province [12] 0 0
Antalya
Country [13] 0 0
Turkey
State/province [13] 0 0
Atakum / Samsun
Country [14] 0 0
Turkey
State/province [14] 0 0
Bursa
Country [15] 0 0
Turkey
State/province [15] 0 0
Emek / Ankara
Country [16] 0 0
Turkey
State/province [16] 0 0
Etlik / Ankara
Country [17] 0 0
Turkey
State/province [17] 0 0
Istanbul
Country [18] 0 0
Turkey
State/province [18] 0 0
Izmir
Country [19] 0 0
Turkey
State/province [19] 0 0
Kocaeli
Country [20] 0 0
Turkey
State/province [20] 0 0
Konya
Country [21] 0 0
Turkey
State/province [21] 0 0
Mersin
Country [22] 0 0
Turkey
State/province [22] 0 0
Meselik / Eskisehir
Country [23] 0 0
Turkey
State/province [23] 0 0
Talas / Kayseri
Country [24] 0 0
Turkey
State/province [24] 0 0
Uskudar / Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00731224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications