New Therapeutics in Alzheimer's Disease Longitudinal Cohort study (NTAD): study protocol.
New Therapeutics in Alzheimer's Disease Longitudinal Cohort study (NTAD): study protocol.
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DOI：
10.1136/bmjopen-2021-055135
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发表时间：
2022-12-15
期刊：
影响因子：
2.9
通讯作者：
Rowe, James B.
中科院分区：
文献类型：
--
作者：
Lanskey, Juliette Helene;Kocagoncu, Ece;Quinn, Andrew J.;Cheng, Yun-Ju;Karadag, Melek;Pitt, Jemma;Lowe, Stephen;Perkinton, Michael;Raymont, Vanessa;Singh, Krish D.;Woolrich, Mark;Nobre, Anna C.;Henson, Richard N.;Rowe, James B.
随着开发延缓或阻止阿尔茨海默病进展的治疗方法的迫切需要，需要新的工具来缩短临床试验持续时间，并验证人类治疗的新靶点。这些工具可以从疾病的神经生理学测量中衍生出来。阿尔茨海默病的新治疗研究旨在从磁学/脑电图学中确定一组生物标记物，该生物标记物对疾病和1 年内的进展敏感。这项研究将招募100名淀粉样蛋白阳性的轻度认知障碍或早期阿尔茨海默病患者和30名年龄在50岁至85岁之间的健康对照组。所有参与者的临床、认知和成像数据(脑磁图、脑电图仪和磁共振成像)的测量将在基线上进行。对于患有阿尔茨海默病或轻度认知障碍的参与者，这些测量将在大约1 年后重复，这些参与者的临床和认知评估将在大约2 年后再次进行。为了评估磁/脑电变化的可靠性，30名患有轻度认知障碍或早期阿尔茨海默病的参与者也将在基线后2 周进行重复磁/脑电检查。神经生理学的基线和纵向变化是主要的分析兴趣。其他产出将包括萎缩和认知变化，以及未来疾病修正疗法的模拟临床试验的每一支手臂治疗所需的估计数量。这项研究得到了英国东部剑桥中央研究伦理委员会的好评(REC Reference 18/EE/0042)。结果将通过内部报告、同行评议的科学期刊、会议介绍、网站发布、提交监管当局和其他出版物传播。在NTAD研究小组完成初步分析后，将通过Dementias平台英国数据门户提供数据。
With the pressing need to develop treatments that slow or stop the progression of Alzheimer’s disease, new tools are needed to reduce clinical trial duration and validate new targets for human therapeutics. Such tools could be derived from neurophysiological measurements of disease. The New Therapeutics in Alzheimer’s Disease study (NTAD) aims to identify a biomarker set from magneto/electroencephalography that is sensitive to disease and progression over 1 year. The study will recruit 100 people with amyloid-positive mild cognitive impairment or early-stage Alzheimer’s disease and 30 healthy controls aged between 50 and 85 years. Measurements of the clinical, cognitive and imaging data (magnetoencephalography, electroencephalography and MRI) of all participants will be taken at baseline. These measurements will be repeated after approximately 1 year on participants with Alzheimer’s disease or mild cognitive impairment, and clinical and cognitive assessment of these participants will be repeated again after approximately 2 years. To assess reliability of magneto/electroencephalographic changes, a subset of 30 participants with mild cognitive impairment or early-stage Alzheimer’s disease will also undergo repeat magneto/electroencephalography 2 weeks after baseline. Baseline and longitudinal changes in neurophysiology are the primary analyses of interest. Additional outputs will include atrophy and cognitive change and estimated numbers needed to treat each arm of simulated clinical trials of a future disease-modifying therapy. The study has received a favourable opinion from the East of England Cambridge Central Research Ethics Committee (REC reference 18/EE/0042). Results will be disseminated through internal reports, peer-reviewed scientific journals, conference presentations, website publication, submission to regulatory authorities and other publications. Data will be made available via the Dementias Platform UK Data Portal on completion of initial analyses by the NTAD study group.
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影响因子：
29
作者：
Donohue, Michael C.;Sperling, Reisa A.;Salmon, David P.;Rentz, Dorene M.;Raman, Rema;Thomas, Ronald G.;Weiner, Michael;Aisen, Paul S.
通讯作者：
Aisen, Paul S.
影响因子：
14
作者：
de Wilde, Martijn C.;Overk, Cassia R.;Sijben, John W.;Masliah, Eliezer
通讯作者：
Masliah, Eliezer
影响因子：
2.9
作者：
Bevan-Jones, W. Richard;Surendranathan, Ajenthan;O'Brien, John T.
通讯作者：
O'Brien, John T.
DOI：
10.1098/rstb.2005.1622
发表时间：
2005-04-29
影响因子：
6.3
作者：
Friston, KJ
通讯作者：
Friston, KJ
影响因子：
14.8
作者：
Bowie, Christopher R.;Harvey, Philip D.
通讯作者：
Harvey, Philip D.