NCT Number: NCT01047579
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.
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Notify MeKey information
Conditions
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Novartis Investigative Site, Ashkelon, Israel
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
- MMSE score of >10 and <26.
- Patients who were under ChE inhibitor treatment and experienced adverse events.
- Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.
Exclusion criteria
- Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
- Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
- History of allergy to topical products containing any of the constitution of the patches.
- Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
- Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
- Patients with body weight less than 40 kg.
Other protocol-defined inclusion/exclusion criteria may apply
Treatment and study plan
Primary outcomes
-
Caregiver questionnaire
Time frame: 12 weeks
Secondary outcomes
-
Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
Time frame: every visit
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Acronym: BETTER
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jan 13, 2010
- Registry last updated
- Feb 24, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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