Rivastigmine Mini-Tablet for Alzheimer's Disease

Peking University

Status: Not yet enrolling

Conditions: Alzheimer's Disease

Treatments: Drug: Rivastigmine Mini-Tablet; Drug: Donepezil Hydrochloride

Study type: Observational

Funder types: Other

Identifiers

NCT06828289

KBLT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Rivastigmine Mini-Tablet

Description:

Start with a dose of 1.5 mg twice daily (bid), titrate every two weeks, and the maximum dose should not exceed 12 mg.

Treatment:

Drug: Rivastigmine Mini-Tablet

Donepezil Hydrochloride

Description:

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.

Treatment:

Drug: Donepezil Hydrochloride