An observational study in Alzheimer's Disease, sponsored by Peking University First Hospital. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Peking University First Hospital · Observational
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Alzheimer's disease
Brain MRI should meet: no infarcts in key areas (thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, etc.), ≤ 2 stroke lesions > 1.5 cm in diameter, and Fazekas Scale - assessed white matter lesion grade
Exclusion Criteria:
Start with a dose of 1.5 mg twice daily (bid), titrate every two weeks, and the maximum dose should not exceed 12 mg.
Drug: Rivastigmine Mini-Tablet
Start with 5mg taken once daily before bedtime. If the patient tolerates the initial dose well, it will be increased to 10 mg per day after four weeks.
Drug: Donepezil Hydrochloride
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University First Hospital