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Not yet recruiting

Rivastigmine Mini-Tablet for Alzheimer's Disease

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

Lead sponsor

Peking University First Hospital

Assets

Donepezil / Rivastigmine

Listed sites

Recruiting sites

Enrollment

1,000

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Identifiers

Registered as

Org study IDKBLT

NCT IDNCT06828289

Timeline

Milestones

Study first posted2025-02-14actual

Last update posted2025-02-20actual

Study start2025-02-28estimated

Primary completion2026-12-31estimated

Study completion2026-12-31estimated

Assets

Drug assets

Donepezil Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Primary/protocol endpoint

Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)

Time frame:Baseline to 12 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline to 12 months

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline to 12 months

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores

Time frame:Baseline to 12 months

Neuropsychiatric Inventory (NPI)

descriptive

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline to 12 months

Phosphorylated tau 217 (p-tau217)

concentration, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and Tolerability

Time frame:Baseline to 12 months

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.