阿尔茨海默病神经影像学倡议4

• Participant may or may not have a significant subjective memory concern as reported by participant, 学习伙伴, 或临床医生.
• Normal memory function documented by scoring above demographically-adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
  • 16年及以上教育年限≥9年
  • 8-15年教育≥5
  • 0-7年教育≥3
  • 注意:随着该领域的发展，截止值可能会随着时间的推移而修改
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• 临床痴呆评分= 0. 记忆盒评分必须为0.
• 认知正常, based on an absence of significant impairment in 认知 functions or activities of daily living.
• 允许药物的稳定性为4周. 具体而言，参与者可以:
  • Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 years)
  • 雌激素替代疗法是允许的
  • 银杏叶是允许的，但不鼓励
  • 精神活性药物的洗脱.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, 等.)进行最少4星期的检查.

• 参与者必须有主观记忆问题，由参与者报告, 学习伙伴, 或临床医生.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
  • 16年及以上教育年限≤11年
  • 8-15年教育≤9
  • 0-7年教育≤6年.
  • 注意:随着该领域的发展，截止值可能会随着时间的推移而修改.
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• 临床痴呆评分= 0.5. 记忆盒分数必须至少为0.5
• General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by the site physician at the time of the screening visit.
• 允许药物的稳定性为4周. 具体而言，参与者可以:
  • Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
  • 雌激素替代疗法是允许的
  • 银杏叶是允许的，但不鼓励
  • 精神活性药物的洗脱.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, 等.)进行最少4星期的检查
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
  • Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen

• 参与者必须有主观记忆问题，由参与者报告, 学习伙伴, 或临床医生.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
  • 16年及以上教育年限≤11年
  • 8-15年教育≤9
  • 0-7年教育≤6年.
  • 注意:随着该领域的发展，截止值可能会随着时间的推移而修改.
• Mini-Mental State Exam score between 20 and 28 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• 临床痴呆评分= 0.5 or 1.0.
• Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines for Dementia (2011)
• 允许药物的稳定性为4周. 具体而言，参与者可以:
  • Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
  • 雌激素替代疗法是允许的
  • 银杏叶是允许的，但不鼓励
  • 精神活性药物的洗脱.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, 等.)进行最少4星期的检查
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
  • Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen

• 老年抑郁量表得分低于10分.
• 年龄介乎55至90岁(含).
• 经常与参与者接触的研究伙伴(如.e., 平均每周最少2小时) and may be able to accompany the participant to clinic visits or provide information remotely (e.g. 通过电话).
• 视觉和听觉的敏锐度足以通过神经心理学测试.
• 总体健康状况良好，无疾病影响研究.
• 参与者未怀孕、哺乳期或具有生育能力.e.(女性必须绝经两年或手术不育).
• 愿意并能够参与纵向成像研究.
• 必须识字并能说流利的英语或西班牙语.
• 同意采集血液进行GWAS, APOE检测，DNA和RNA检测
• 同意采集血液进行生物标志物检测.
• 第9节描述的行政核心.1.1, will collaborate with leadership from all Cores to review the blood biomarker data from the remote blood cohort and select participants to join the in-clinic cohort. 参见ADNI4:远程协议.
• Agrees to participate in the ADNI study which includes 认知 evaluation, MRI and PET scans.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.

• Must have been enrolled and followed in one of the following previous ADNI studies: ADNIGO, ADNI2, ADNI3至少一年.
• 愿意并能够继续参与正在进行的纵向研究. 允许减少一系列测试.
• 可能会有与参与者有频繁联系的研究伙伴(例如.e., 平均每周最少2小时), and may be able to accompany the participant to clinic visits or provide information remotely (e.g. 通过电话).

1.任何严重的神经系统疾病, 比如帕金森病, 血管性认知障碍/痴呆, 亨廷顿氏舞蹈症, 正常压力脑积水, 脑瘤, 进行性核上性麻痹, 癫痫发作, 硬脑膜下血肿, 多发性硬化症, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities

1.除疑似阿尔茨海默病外的任何重大神经系统疾病, 比如帕金森病 (Parkinsonian symptoms complicating MCI/AD are acceptable), 血管性认知障碍性痴呆(多腔隙小于等于1).5厘米和/或广泛的白质改变是可以接受的), 亨廷顿氏舞蹈症, 正常压力脑积水, 脑瘤(临床不明显的脑膜瘤可接受), 进行性核上性麻痹, 癫痫发作, 硬脑膜下血肿, 多发性硬化症, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

• 有感染证据的筛查/基线MRI脑扫描, 或其他临床显著的局灶性病变. 脑皮层中风的参与者, 不会大到扭曲解剖结构, 多发性腔隙性梗死或广泛的白质疾病是允许的.
• Screening/Baseline MRI brain scan with evidence of large structural abnormalities that would corrupt image analytical pipelines - e.g. 大面积脑半球梗死，大面积脑软化，大蛛网膜囊肿
• 由于任何原因无法完成核磁共振(mri).g. 起搏器或其他植入式金属装置, 严重的幽闭恐怖症, 阻止核磁共振扫描的焦虑, 太大不合适, 等.).
• Current major depression, bipolar disorder as described in DMS-IV within the past 1 year. 精神病症状, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
• Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
• 精神分裂症病史(DSM-5标准).
• 过去2年内有酒精或物质障碍史(DSM-5标准).
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
• 有临床意义的B12异常, 或者甲状腺功能测试可能会干扰研究. 低B12是排他性的, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
• 住在专业护理机构
• 目前使用的特定精神活性药物(如.g. 某些抗抑郁药、神经抑制剂、慢性抗焦虑药或镇静催眠药等.)，由临床医生酌情决定.
• 目前是否使用其他排他性药物.
• 在5个半衰期或1个月内禁止使用研究药物, 以较长的时间段为准, 在进入试验前和试验期间.
• Participation in clinical studies involving neuropsychological measures being collected more than once time per year.
• 孕妇:怀孕、哺乳或有生育能力的女性.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.