Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529619
• Other study ID #: CENA713D1403
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2012
• Last updated: November 16, 2016
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine transdermal patch

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Kamakura-city	Kanagawa
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Koshi-city	Kumamoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Miyoshi-city	Hiroshima
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Ohtake	Hiroshima
Japan	Novartis Investigative Site	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)	The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.	Baseline and Week 24	No
Secondary	Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug	Adverse Events: An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug.	Week 24	Yes
Secondary	Change From Baseline in Disability Assessment for Dementia (DAD)	The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.	Baseline and Week 24	No
Secondary	Change From Baseline in Mini-Mental State Examination (MMSE)	The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.	Baseline and Week 24	No
Secondary	Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)	The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated).	Week 4, 8, 12, 16, 20, 24	No
Secondary	Change From Baseline in Modified Crichton Scale	Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment.; Orientation, Conversation, Cooperation with family and caregiver, Restlessness, Dressing and clothes, Job and social activities/roles, Leisure activities	Baseline and Week 4, 8, 12, 16, 20, 24	No
Secondary	Formulation usability questionnaire	The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown). The reason for the answer should be recorded as possible.	Week 24	No

External Links

•   Results for CENA713D1403 from the Novartis Clinical Trials website