Rivastigmine Mini-Tablet for Alzheimer's Disease

Observational Study of Rivastigmine Mini-Tablet in Patients with Alzheimer's Disease

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Rivastigmine Mini-Tablet; Drug: Donepezil Hydrochloride

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yongan Sun, Phd; Phone Number: 83572462; Email: sya@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Alzheimer's disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Rivastigmine Mini-Tablet; Treatment group: Rivastigmine Mini-Tablet
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.	Drug: Donepezil Hydrochloride; Control group: Donepezil Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Safety and Tolerability	The adverse event, discontinuation due to intolerability, etc will be monitored.	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.	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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Yongan Sun, Phd, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Protective Agents; Neuroprotective Agents; Cholinergic Agents; Nootropic Agents; Cholinesterase Inhibitors; Donepezil; Rivastigmine
• Other Study ID Numbers: KBLT

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No