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
基本信息
- 批准号:10677333
- 负责人:
- 金额:$ 73.35万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdultAgeAlzheimer&aposs DiseaseAlzheimer&aposs disease riskAmyloid beta-42Amyloid beta-ProteinAnimalsAnti-Inflammatory AgentsAnxietyBiological MarkersCannabidiolCannabinoidsCognitionCognitiveColoradoControlled Clinical TrialsDataDementiaDoseDouble-Blind MethodDown-RegulationElderlyEndocannabinoidsHealthHempHydroxyeicosatetraenoic AcidsImpaired cognitionIndividualInferiorInflammationInflammatoryJournalsLightLinkLipidsMarketingMeasuresMediatingMental DepressionMorbidity - disease rateNerve DegenerationOutcomeOutcome MeasureOxidative StressPainPain interferencePatientsPlacebo ControlPlacebosPlasmaPopulationPrevalencePropertyProstaglandin D2Public HealthPublishingRandomizedResearchSignal TransductionSleepSleep disturbancesSurveysTestingTimeUnited StatesUp-RegulationWorkaging populationbehavior measurementdesigndouble-blind placebo controlled trialeconomic costepidemiologic datahigh riskhuman old age (65+)improvement on sleepmild cognitive impairmentmortalitynegative affectneurofilamentneuroprotectionpre-clinicalpreventprimary outcomeprogression markerpublic health researchrandomized placebo controlled trialsecondary outcomesleep qualitysleep quantitysocioeconomicstau-1trend
项目摘要
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)。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Angela Bryan其他文献
Angela Bryan的其他文献
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{{ truncateString('Angela Bryan', 18)}}的其他基金
Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC
大麻用于癌症姑息治疗:全谱大麻衍生 CBD/THC 的安慰剂对照随机试验
- 批准号:
10754176 - 财政年份:2023
- 资助金额:
$ 73.35万 - 项目类别:
Exercise adherence and cognitive decline: Engaging with the Black community to develop and test a goal-setting and exercise intensity intervention
运动坚持和认知能力下降:与黑人社区合作制定和测试目标设定和运动强度干预措施
- 批准号:
10767102 - 财政年份:2023
- 资助金额:
$ 73.35万 - 项目类别:
Cannabis use among older adults: Potential risks and benefits to an aging population
老年人吸食大麻:人口老龄化的潜在风险和益处
- 批准号:
10563144 - 财政年份:2021
- 资助金额:
$ 73.35万 - 项目类别:
Cannabis use among older adults: Potential risks and benefits to an aging population
老年人吸食大麻:人口老龄化的潜在风险和益处
- 批准号:
10348730 - 财政年份:2021
- 资助金额:
$ 73.35万 - 项目类别:
Exploring the anti-inflammatory properties of cannabis and their relevance to insulin sensitivity
探索大麻的抗炎特性及其与胰岛素敏感性的相关性
- 批准号:
10160867 - 财政年份:2019
- 资助金额:
$ 73.35万 - 项目类别:
Exploring the anti-inflammatory properties of cannabis and their relevance to insulin sensitivity
探索大麻的抗炎特性及其与胰岛素敏感性的相关性
- 批准号:
10400315 - 财政年份:2019
- 资助金额:
$ 73.35万 - 项目类别:
Exploring the anti-inflammatory properties of cannabis and their relevance to insulin sensitivity
探索大麻的抗炎特性及其与胰岛素敏感性的相关性
- 批准号:
10619625 - 财政年份:2019
- 资助金额:
$ 73.35万 - 项目类别:
Exploring the anti-inflammatory properties of cannabis and their relevance to insulin sensitivity
探索大麻的抗炎特性及其与胰岛素敏感性的相关性
- 批准号:
10409678 - 财政年份:2019
- 资助金额:
$ 73.35万 - 项目类别:
Exercise and markers of medial temporal health in youth at-risk for psychosis
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- 批准号:
9321907 - 财政年份:2016
- 资助金额:
$ 73.35万 - 项目类别:
Exercise and markers of medial temporal health in youth at-risk for psychosis
有精神病风险的青少年的运动和内侧颞叶健康指标
- 批准号:
9131473 - 财政年份:2016
- 资助金额:
$ 73.35万 - 项目类别:
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