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NCT Number: NCT06828289

Rivastigmine Mini-Tablet for 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).

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Key information

Conditions

Alzheimer's Disease

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine Mini-Tablet

Drug

Treatment group: Rivastigmine Mini-Tablet

Donepezil Hydrochloride

Drug

Control group: Donepezil Hydrochloride

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline to 12 months

    MMSE range 0-30, with higher scores indicating better cognitve functioning.

  2. Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores

    Time frame: Baseline to 12 months

    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.

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

    Time frame: Baseline to 12 months

    ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities.

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

    Time frame: Baseline to 12 months

    The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP.

  5. Safety and Tolerability

    Time frame: Baseline to 12 months

    The adverse event, discontinuation due to intolerability, etc will be monitored.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongan Sun, Phd

CONTACT

[email protected]

83572462

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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