Alzheimer's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : Rivastigmine Patch
INN of investigational material : rivastigmine
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage an
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Outpatient status at baseline. -A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria. -A clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. -Patients with MMSE score of >= 10 and = 2 points of MMSE despite of treatment of other oral Cholinesterase (ChE) inhibitors in initial 3-month. -Patients who declined >= 2 points of MMSE in last 6 months with other oral ChE inhibitors (ChEI). -Patients who show marked worsening of BPSD, or ADL (can be defined by 1state progression of FAST) judged by a physician despite of treatment of other oral ChE inhibitors in initial 3-month or last 6-month with other oral ChE inhibitors -Patients having difficulties being treated orally with ChEIs (donepezil or galantamine) by physician's judgement. -Poor compliance or adverse event except GI symptoms -Patients with swallowing difficulties.
Exclusion criteria
Exclusion criteria: -Any medical or neurological condition other than AD that could explain the patient's dementia (e.g., abnormal thyroid function tests, vitamin B12 or folate deficiency, posttraumatic conditions, syphilis, head injury, Huntington's disease, Parkinson's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor) at baseline -Any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder -Current diagnosis of an active skin lesion/disorder -Patients with a history of hypersensitivity to any ingredients of rivastigmine or carbamate derivatives -An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline to week 24 in the total score of Mini-Mental State Examination (MMSE) To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs). To evaluate the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks. efficacy Change from baseline to Week 8 in Mini-Mental State Examination (MMSE) total score. To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8. efficacy Change in Neuropsychiatric Inventory - 10 Item (NPI-10) score from baseline to week 8 and week 24 To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the Neuropsychiatric Inventory - 10 Item (NPI-10)score at week 8 and week 24. efficacy Change in QOL-AD score from baseline to week 24 To evaluate the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24. efficacy Change in J-CGIC score from baseline to week 4, 8, 16 and 24 To evaluate the efficacy of rivastigmine patch with 1-step titration measured as the J-CGIC score at week 4, week 8, week 16 and week 24 efficacy Change in as Modified Crichton Scale score from baseline to week 4, 8, 16 and 24 To evaluate the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24. other Formulation usability score up to week 24 To evaluate the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver. | — |
Countries
Japan
Outcome results
None listed