Alzheimer's Disease
Conditions
Keywords
Rivastigmine, Alzheimer's disease, Transdermal patch
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.
Interventions
Sponsors
Ono Pharmaceutical Co. Ltd
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog) | Baseline and Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disability Assessment for Dementia (DAD) | Baseline and Week 24 | 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. |
| Change From Baseline in Mini-Mental State Examination (MMSE) | Baseline and Week 24 | 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. |
| Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug | Week 24 | 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. |
| Change From Baseline in Modified Crichton Scale | Baseline and Week 4, 8, 12, 16, 20, 24 | 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 |
| Formulation usability questionnaire | Week 24 | 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. |
| Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC) | Week 4, 8, 12, 16, 20, 24 | 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). |
Countries
Japan
Outcome results
None listed