Alzheimer's DiseaseNCT06828289
Rivastigmine Mini-Tablet for Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Peking University First Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine Mini-Tablet and Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Alzheimer's disease
Who may be able to join
- 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
Show all 9Show fewer
- 2.
- Patients whose caregivers are well-informed about the patients' condition and, if possible, live with them.
- Provide written informed consent
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine Mini-Tablet, Donepezil Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine Mini-TabletDrug
Treatment group: Rivastigmine Mini-Tablet
Donepezil HydrochlorideDrug
Control group: Donepezil Hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)
CDR-SB range 0-18, with higher scores indicating more severe dementia.
Measured: Baseline to 12 months
Secondary outcomes (5)
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
MMSE range 0-30, with higher scores indicating better cognitve functioning.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Safety and Tolerability
The adverse event, discontinuation due to intolerability, etc will be monitored.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongan Sun, Phd, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828289
- Sponsor's protocol ID
- KBLT
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Rivastigmine Mini-Tablet in Patients with Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06828289
- Acronym / sponsor ID
- KBLT
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine Mini-Tablet | – | Drug: Rivastigmine Mini-TabletStart with a dose of 1.5 mg twice daily (bid), titrate every two weeks, and the maximum dose should not exceed 12 mg. |
| Donepezil Hydrochloride | – | Drug: Donepezil HydrochlorideStart 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's disease
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine Mini-TabletTreatment group: Rivastigmine Mini-Tablet | Drug | Rivastigmine Mini-Tablet |
| Donepezil HydrochlorideControl group: Donepezil Hydrochloride | Drug | Donepezil Hydrochloride |
Primary outcome
Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)
Time frame: Baseline to 12 months
CDR-SB range 0-18, with higher scores indicating more severe dementia.
5 secondary outcomes
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
Time frame: Baseline to 12 months
Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
Time frame: Baseline to 12 months
Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores
Time frame: Baseline to 12 months
Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP）
Time frame: Baseline to 12 months
Safety and Tolerability
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongan Sun, Phd principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongan Sun, Phd (83572462, sya@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.