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OpenTrials
Completed

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ashkelon, Israel

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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

Rivastigmine transdermal

Drug

Primary outcomes

  1. Caregiver questionnaire

    Time frame: 12 weeks

Secondary outcomes

  1. 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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