Clinical trial NCT06828289: Rivastigmine Mini-Tablet for Alzheimer's Disease
Official title: Observational Study of Rivastigmine Mini-Tablet in Patients with Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer&#39;s Disease
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
timeFrame: Baseline to 12 months
measure: Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
timeFrame: Baseline to 12 months
measure: Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores
timeFrame: Baseline to 12 months
measure: Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP）
timeFrame: Baseline to 12 months
measure: Safety and Tolerability
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Yongan Sun, Phd
role: PRINCIPAL_INVESTIGATOR
References: