The objective of this study is to evaluate the efficacy and safety of rivastigmine mini-tablets in individuals diagnosed with mild to moderate Alzheimer's disease (AD).
Rivastigmine has received approval for the treatment of Alzheimer's disease. The rivastigmine mini-tablet represents an innovative drug formulation designed to address swallowing difficulties by reducing the size of the dosage form, while also minimizing gastrointestinal side effects through an optimized drug release mechanism. This multi-center, observational study aims to evaluate the effectiveness, safety, and patient compliance associated with rivastigmine mini-tablets in individuals diagnosed with Alzheimer's disease. Assessments will be conducted at the 3rd, 6th, and 12th months of treatment.
Study Type
OBSERVATIONAL
Enrollment
1,000
Treatment group: Rivastigmine Mini-Tablet
Control group: Donepezil Hydrochloride
Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)
CDR-SB range 0-18, with higher scores indicating more severe dementia.
Time frame: Baseline to 12 months
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
MMSE range 0-30, with higher scores indicating better cognitve functioning.
Time frame: Baseline to 12 months
Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
NPI score range is 0-144 for patient assessment and 0-60 for caregiver distress assessment. In patient assessment, higher scores indicate more severe neuropsychiatric disorders; in caregiver distress assessment, higher scores indicate greater distress.
Time frame: Baseline to 12 months
Changes from baseline in Alzheimer's Disease Cooperative Study ADL(ADCS-ADL)) scores
ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities.
Time frame: Baseline to 12 months
Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP)
The plasma biomarkers include Aβ42/40,p-tau181, p-tau217, NfL and GFAP.
Time frame: Baseline to 12 months
Safety and Tolerability
The adverse event, discontinuation due to intolerability, etc will be monitored.
Time frame: Baseline to 12 months
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