Rivastigmine Mini-Tablet for Alzheimer's Disease

Not yet recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: Donepezil Hydrochloride; Drug: Rivastigmine Mini-Tablet

• Registration Number: NCT06828289
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Start: 2025-02-28
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Donepezil Hydrochloride	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.
Rivastigmine Mini-Tablet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.