Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial

大麻二酚对有阿尔茨海默病风险的个体来说：一项随机安慰剂对照试验

• 批准号: 10677333
• 负责人: Angela Bryan
• 金额: $ 73.35万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677333
• 关键词: Address; Adult; Age; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid beta-42; Amyloid beta-Protein; Animals; Anti-Inflammatory Agents; Anxiety; Biological Markers; Cannabidiol; Cannabinoids; Cognition; Cognitive; Colorado; Controlled Clinical Trials; Data; Dementia; Dose; Double-Blind Method; Down-Regulation; Elderly; Endocannabinoids; Health; Hemp; Hydroxyeicosatetraenoic Acids; Impaired cognition; Individual; Inferior; Inflammation; Inflammatory; Journals; Light; Link; Lipids; Marketing; Measures; Mediating; Mental Depression; Morbidity - disease rate; Nerve Degeneration; Outcome; Outcome Measure; Oxidative Stress; Pain; Pain interference; Patients; Placebo Control; Placebos; Plasma; Population; Prevalence; Property; Prostaglandin D2; Public Health; Publishing; Randomized; Research; Signal Transduction; Sleep; Sleep disturbances; Surveys; Testing; Time; United States; Up-Regulation; Work; aging population; behavior measurement; design; double-blind placebo controlled trial; economic cost; epidemiologic data; high risk; human old age (65+); improvement on sleep; mild cognitive impairment; mortality; negative affect; neurofilament; neuroprotection; pre-clinical; prevent; primary outcome; progression marker; public health research; randomized placebo controlled trial; secondary outcome; sleep quality; sleep quantity; socioeconomics; tau-1; trend

Research Summary Epidemiological data have indicated that the use of products with cannabidiol (CBD) and other cannabinoids have increased dramatically among adults over the age of 65. Recent survey data collected in Colorado indicate that older adults who use cannabinoids believe that it helps alleviate pain, helps improve sleep quality, and decreases negative affect (i.e., depression, anxiety). Older adults may also be taking cannabinoids like CBD because they believe it might have a positive impact on the progression of dementia and cognitive decline, as popularized by a recent Discover magazine article. Given the aforementioned socioeconomic trends, the preclinical data suggesting that CBD may be neuroprotective, and our preliminary data suggesting that CBD impacts key biomarkers of inflammation and oxidative stress, it is clearly time to assess the impact of these products on the cognitive health of older adults who are at high risk for AD. The significance of this question is underscored by both the rapidly aging population in the U.S. (>60 million adults over the age of 65 by 2025), the prevalence of MCI (~15–20%) and Alzheimer’s (about 10% or 6-7 million), as well as the enormous mortality, morbidity, and socioeconomic costs of AD. The proposed research will address this public health research need with a gold standard, 24 week, randomized, double-blind, placebo-controlled clinical trial (RCT) comparing full spectrum hemp-derived CBD, to CBD alone, and to placebo. The proposed study will determine whether CBD impacts the progression of biomarkers related to neurodegeneration and Alzheimer’s disease and determine whether CBD impacts measures of anxiety, depression, sleep, and pain in a population at high risk for AD. The research will also determine whether any effects of CBD on outcomes are mediated by the effect of CBD on biomarkers of inflammation and oxidative stress and/or changes in endocannabinoids. Given the number of older adults at risk for AD who are using CBD products and given that these individuals believe that these products are helpful, the proposed well-controlled trial will have a significant impact by informing the public about the effects of CBD, regardless of the outcome of the analyses (positive or negative).

研究综述 流行病学数据表明，使用含有大麻二酚（CBD）和其他大麻素的产品 在65岁以上的成年人中急剧增加。最近在科罗拉多收集的调查数据 表明使用大麻素的老年人认为它有助于减轻疼痛，有助于改善睡眠质量， 并减少负面影响（即，抑郁、焦虑）。老年人也可能服用大麻素， CBD，因为他们认为它可能对痴呆症和认知障碍的进展产生积极影响。 正如最近《发现》杂志的一篇文章所宣传的那样，鉴于上述社会经济 趋势，临床前数据表明CBD可能具有神经保护作用，我们的初步数据表明 CBD影响炎症和氧化应激的关键生物标志物，现在显然是时候评估 这些产品对AD高危老年人的认知健康的影响。其意义 美国人口的迅速老龄化（超过6000万65岁以上的成年人） 到2025年），MCI（~15-20%）和阿尔茨海默氏症（约10%或6-7百万）的患病率，以及 AD的巨大死亡率、发病率和社会经济成本。这项研究将解决这一公众 健康研究需要金标准、24周、随机、双盲、安慰剂对照临床试验 (RCT)将全谱大麻衍生的CBD与单独的CBD和安慰剂进行比较。拟定的研究将 确定CBD是否影响与神经退行性变和阿尔茨海默氏症相关的生物标志物的进展 疾病，并确定CBD是否影响人群中的焦虑，抑郁，睡眠和疼痛的测量 AD的高风险。该研究还将确定CBD对结果的任何影响是否由以下因素介导： CBD对炎症和氧化应激的生物标志物和/或内源性大麻素变化的影响。 考虑到使用CBD产品的老年人有AD风险的人数， 相信这些产品是有帮助的，拟议的对照良好的试验将产生重大影响， 向公众宣传《生物多样性公约》的影响，无论分析结果如何（积极或消极）。