Alzheimer's Disease
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGRivastigmine Mini-Tablet
Treatment group: Rivastigmine Mini-Tablet
DRUGDonepezil Hydrochloride
Control group: Donepezil Hydrochloride
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 50 or older * Meet the National Institute of Aging-Alzheimer's Association clinical criteria for probable Alzheimer's disease * Have a Mini-Mental State Examination score of 10 to 24 at Screening and Baseline * Geriatric Depression Scale score \<=7 at Screening * Hachinski Ischemic Scale \<=4 at Screening * 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 * 2\. * Patients whose caregivers are well-informed about the patients' condition and, if possible, live with them. * Provide written informed consent
Exclusion criteria
* Any systemic or neurological condition that could contribute to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease * Any psychiatric diagnosis or symptoms (hallucinations, major depression, delusions, etc) interfering with study procedures * An advanced, severe or unstable disease of any type (cardiac, respiratory, gastrointestinal, renal disease, etc) that may interfere with efficacy evaluations * Subjects treated with medication for dementia two weeks prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) | Baseline to 12 months | CDR-SB range 0-18, with higher scores indicating more severe dementia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Mini-Mental State Examination (MMSE) scale scores | Baseline to 12 months | MMSE range 0-30, with higher scores indicating better cognitve functioning. |
| Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores | Baseline to 12 months | 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. |
| Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores | Baseline to 12 months | ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities. |
| Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） | Baseline to 12 months | The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP. |
| Safety and Tolerability | Baseline to 12 months | The adverse event, discontinuation due to intolerability, etc will be monitored. |
Contacts
Primary ContactYongan Sun, Phd
Outcome results
None listed