Rivastigmine Mini-Tablet for Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivastigmine Mini-Tablet, Donepezil Hydrochloride.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study of Rivastigmine Mini-Tablet in Patients with Alzheimer's Disease
Overview
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
- Drug Rivastigmine Mini-Tablet
Treatment group: Rivastigmine Mini-Tablet - Drug Donepezil Hydrochloride
Control group: Donepezil Hydrochloride
Primary outcome measures
- Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) [Time frame: Baseline to 12 months]
Secondary outcome measures (5)
- Changes from baseline in Mini-Mental State Examination (MMSE) scale scores [Time frame: Baseline to 12 months]
- Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores [Time frame: Baseline to 12 months]
- Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores [Time frame: Baseline to 12 months]
- Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） [Time frame: Baseline to 12 months]
- Safety and Tolerability [Time frame: Baseline to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06828289 · KBLT