Clinical trial NCT01529619: Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors
Official title: A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-23) Switched From Cholinesterase Inhibitors (Donepezil, Galantamine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Rivastigmine
Alzheimer's disease
Transdermal patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2012-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of \> or = 10 and \< or = 23
* Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
* Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
* Inadequate compliance with the ChE inhibitors at screening and baseline
* Presence of caregiver's burden for administering drugs orally at screening and baseline
* Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
* Patients with swallowing difficulties at screening and baseline

Exclusion Criteria:

* A current DSM-IV diagnosis of major depression
* Taken rivastigmine in the past
* A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug
timeFrame: Week 24
measure: Change From Baseline in Disability Assessment for Dementia (DAD)
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline and Week 24
measure: Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)
timeFrame: Week 4, 8, 12, 16, 20, 24
measure: Change From Baseline in Modified Crichton Scale
timeFrame: Baseline and Week 4, 8, 12, 16, 20, 24
measure: Formulation usability questionnaire
timeFrame: Week 24
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Miyoshi-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Ohtake
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kamakura-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshi-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: