Probucol in Alzheimer's Study 2020 (PIA 2020)

The aim of this study is to understand whether or not treatment with Probucol supports cognitive function in participants with MCI/mild-dementia due to AD. The trial is specifically designed to provide evidence that treatment with Probucol may slow the decline of cognitive ability and functional state. The presence of cognitive impairment will be assessed using neuro-cognitive assessments. Participants will be randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). This is a double-blind trial meaning the participant and study doctor will not be aware which group the participant has been randomised to. The study will be 104 weeks in duration (2 years). Participants will be required to take one tablet a day (with food) for the first three weeks, and then two tablets a day (morning and night, with food) for the remainder of the trial. During the screening/pre-baseline phase participants will be asked about their medical history, complete a physical and neurological examination, an Electrocardiogram (ECG), and a blood test. Participants will also complete Neuro-cognitive assessments (memory and thinking tasks), as well as a Magnetic Resonance Imaging (MRI) scan and/or a Positron emission tomography (PET) scan. During the treatment phase, participants will be required to visit the study doctor on 10 separate occasions (once a week for the first 3 weeks, and then at approximately 3 monthly intervals). Each visit will involve a health and safety assessment. Neuro-cognitive assessments will also be conducted at week 26 (6 months), 52 (12 months), and 78 (18 months). A blood sample will also be taken at each visit. At completion of the treatment phase (week 104), participants will recomplete the Neuro-cognitive assessments, MRI and/or PET scan, and provide a final blood sample. During the course of the trial, participants will be required to nominate a 'study partner' (spouse/partner/carer). The study partner will need to attend at least one screening visit. In addition, study partners should make themselves available by phone or preferably in person, to provide information to the study as required. Participants will need to identify a study partner to be eligible to take part in this study. Meta Data Link: https://wahesanda.blob.core.windows.net/meta/PIA.zip

本研究旨在探究普罗布考（Probucol）治疗是否可维持阿尔茨海默病（AD）所致轻度认知障碍（MCI）/轻度痴呆患者的认知功能。本试验专门设计以提供证据，证明普罗布考治疗或可延缓认知能力与功能状态的衰退。认知损害程度将通过神经认知评估手段进行评定。受试者将被随机分配至两组：组1（安慰剂组）与组2（治疗组）。本试验为双盲研究，即受试者与研究医师均无法获知受试者被分配至哪一组。本研究周期为104周（即2年）。受试者需在前3周每日随餐服用1片药物，后续试验阶段则改为每日早、晚各随餐服用1片，即每日2片。

在筛查/预基线阶段，受试者将被询问病史，完成体格检查与神经系统检查、心电图（Electrocardiogram, ECG）检测及血液检验。此外，受试者还需完成神经认知评估（记忆与思维任务），并接受磁共振成像（Magnetic Resonance Imaging, MRI）扫描和/或正电子发射断层扫描（Positron emission tomography, PET）扫描。

在治疗阶段，受试者需共计10次前往研究医师处就诊：前3周每周就诊1次，后续约每3个月就诊1次。每次就诊均需进行健康与安全评估。神经认知评估将分别在第26周（6个月）、第52周（12个月）及第78周（18个月）开展。每次就诊时还将采集血液样本。

在治疗阶段结束（第104周）时，受试者需重新完成神经认知评估、MRI和/或PET扫描，并提供最终血液样本。

试验期间，受试者需指定一名“研究搭档”（配偶/伴侣/护理者）。该研究搭档需至少参与1次筛查就诊。此外，研究搭档应通过电话或（优先采用当面方式）随时待命，按需向研究团队提供相关信息。受试者必须指定一名研究搭档方可符合本研究的入组资格。
元数据链接：https://wahesanda.blob.core.windows.net/meta/PIA.zip