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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine Mini-Tablet | Start with a dose of 1.5 mg twice daily (bid), titrate every two weeks, and the maximum dose should not exceed 12 mg. |
| |
| Donepezil Hydrochloride | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine Mini-Tablet | Drug | Treatment group: Rivastigmine Mini-Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) | CDR-SB range 0-18, with higher scores indicating more severe dementia. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Mini-Mental State Examination (MMSE) scale scores | MMSE range 0-30, with higher scores indicating better cognitve functioning. | Baseline to 12 months |
| Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores |
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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
Patients whose caregivers are well-informed about the patients' condition and, if possible, live with them.
Provide written informed consent
Exclusion Criteria:
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Patients with Alzheimer's disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongan Sun, Phd | Contact | 83572462 | sya@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongan Sun, Phd | Peking University First Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Donepezil Hydrochloride |
| Drug |
Control group: Donepezil Hydrochloride |
|
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.
| 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. | 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. | Baseline to 12 months |
| Safety and Tolerability | The adverse event, discontinuation due to intolerability, etc will be monitored. | Baseline to 12 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |