A Phase 4 interventional study of Rivastigmine transdermal patch in Alzheimer's Disease, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Japan. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
Drug: Rivastigmine transdermal patch
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.
Time frame: Baseline and Week 24
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.
Time frame: Week 24
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.
Time frame: Baseline and Week 24
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.
Time frame: Baseline and Week 24
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).
Time frame: Week 4, 8, 12, 16, 20, 24
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
Time frame: Baseline and Week 4, 8, 12, 16, 20, 24
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.
Time frame: Week 24
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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