Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2025-02-28
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
NCT00219232
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
NCT02079909
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
NCT02989402
Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
NCT01380288
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
NCT02444637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Donepezil Hydrochloride
Control group: Donepezil Hydrochloride
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivastigmine Mini-Tablet
Treatment group: Rivastigmine Mini-Tablet
Donepezil Hydrochloride
Control group: Donepezil Hydrochloride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University First Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yongan Sun, Phd
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KBLT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.