Rivastigmine Mini-Tablet for Alzheimer's Disease

NCT06828289 | Not Yet Recruiting

• 1 other identifier: KBLT
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes from baseline in Mini-Mental State Examination (MMSE) scale scores

  Baseline to 12 months

• Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores

  Baseline to 12 months

• Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores

  Baseline to 12 months

• Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP）

  Baseline to 12 months

• Safety and Tolerability

  Baseline to 12 months

Study Arms (2)

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

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

Interventions

Rivastigmine Mini-Tablet DRUG

Treatment group: Rivastigmine Mini-Tablet

Rivastigmine Mini-Tablet

Donepezil Hydrochloride DRUG

Control group: Donepezil Hydrochloride

Donepezil Hydrochloride

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Alzheimer's disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Yongan Sun, Phd

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongan Sun, Phd

CONTACT

83572462; sya@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 14, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02