| November 19, 2007 |
| November 20, 2008 |
| October 2007 |
| October 2008 (final data collection date for primary outcome measure) |
| Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks). [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ] |
| Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks). |
| Complete list of historical versions of study NCT00561392 on ClinicalTrials.gov Archive Site |
- Cognitive and global outcome of the patients:
Mini-Mental-State-Examination [ Time Frame: Screening, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change [ Time Frame: after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
- Trail Making Test A [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
- Activities of Daily living [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
- Safety/tolerability data (AEs and SAEs) [ Time Frame: Throughout the trial ] [ Designated as safety issue: Yes ]
- Patient compliance with the patch (drug accounting) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- Caregiver preference and satisfaction with the patch [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Caregiver burden (mini-Zarit score) [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
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- Cognitive and global outcome of the patients:
Mini-Mental-State-Examination (Screening, after 4, 8 and 24 weeks)
- Clinical Global Impression of Change (after 4, 8 and 24 weeks)
- Trail Making Test A (Baseline, after 4, 8 and 24 weeks)
- Activities of Daily living (Baseline, after 4, 8 and 24 weeks)
- Safety/tolerability data (AEs and SAEs)
- Patient compliance with the patch (drug accounting)
- Caregiver preference and satisfaction with the patch
- Caregiver burden (mini-Zarit score, Baseline, after 4, 8 and 24 weeks)
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| Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease |
| A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26) |
This study will evaluate the safety and efficacy of 10 cm2 Rivastigmine Patch in patients with Alzheimer Disease (MMSE 10-26). Primary objective is the percentage of patients who stay on the target size of 10 cm2 for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Rivastigmine trials. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Alzheimer's Disease |
| Drug: Rivastigmine |
| |
| |
| |
| Active, not recruiting |
| 200 |
|
| October 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 DSMIV (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
Exclusion Criteria:
- 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);
Other protocol-defined exclusion criteria may apply. |
| Both |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00561392 |
| External Affairs, Novartis |
| CENA713DDE15 |
| Novartis |
|
| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
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| Novartis |
| November 2008 |