Rivastigmine Mini-Tablet for Alzheimer's Disease

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Rivastigmine Mini-Tablet
  Treatment group: Rivastigmine Mini-Tablet
• Препарат Donepezil Hydrochloride
  Control group: Donepezil Hydrochloride

Первичные конечные точки

• Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (5)

• Changes from baseline in Mini-Mental State Examination (MMSE) scale scores [Срок оценки: Baseline to 12 months]
• Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores [Срок оценки: Baseline to 12 months]
• Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores [Срок оценки: Baseline to 12 months]
• Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） [Срок оценки: Baseline to 12 months]
• Safety and Tolerability [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06828289 · KBLT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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