Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot
Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot
批准号:
10077807
负责人:
SASCHA DUBLIN
金额:
$164.79万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-09-15 至 2023-11-30
关键词:
Activities of Daily LivingAddressAffectAgeAlzheimer disease preventionAlzheimer&aposs DiseaseAlzheimer&aposs disease related dementiaAlzheimer&aposs disease riskAreaBenefits and RisksCardiovascular DiseasesCognitionCognitiveCohort StudiesCost of IllnessCountryDataDementiaDiabetes MellitusDietDiseaseEducationElderlyEuropeFutureGoalsHealthHealth educationHealthcare SystemsHypertensionImpaired cognitionIncidenceIndividualIntegrated Delivery of Health CareInterventionIntervention StudiesLife StyleMedicalMedication ManagementMental DepressionObesityOutcomeParticipantPatientsPerformancePharmaceutical PreparationsPhysical PerformancePilot ProjectsPopulationPopulation StudyPreparationPrevalencePreventionPrevention trialPrimary PreventionPsyche structurePublic HealthQuality of lifeRandomizedRisk FactorsRisk ManagementRisk ReductionSample SizeSiteSleepSmokingSystemTechnologyTestingWorkbasebehavior changebrain healthcardiovascular risk factorcognitive changecognitive testingdepressive symptomsexperiencefeasibility testinggood dietgroup interventionhealth care deliveryhealth care settingshealthy lifestylehigh riskhigh risk populationimprovedinnovationinterestmild cognitive impairmentmodifiable riskmotivated behaviormulti-site trialmultimodalitynovelolder patientpersonalized interventionphase III trialphysical inactivitypilot trialpopulation basedpreventprimary outcomeprogramssecondary outcomesleep qualitysmoking cessationsocialtherapy design
中文摘要
预计到2050年,阿尔茨海默病的患病率将增加两倍,目前的药物治疗不会改变阿尔茨海默病的发病率。
病程。然而,最近的研究预测,高达30%的阿尔茨海默病可能是
通过针对可改变的风险因素来预防。事实上,基于人口的研究发现,尽管
痴呆症病例总数正在增加,特定年龄的发病率正在下降,
人口一级的风险因素,如教育程度低,吸烟和心血管疾病的减少。
此外,欧洲的研究表明,
多领域的减少风险干预措施。考虑到预防阿尔茨海默病的重要性以及
降低风险对一般和大脑健康的好处,即使是阿尔茨海默氏症的相对较小的减少,
发病率将对公共卫生产生巨大影响。尽管多领域的巨大前景
风险降低方法,在美国没有进行一级预防试验,我们建议进行
在美国进行的一项多领域阿尔茨海默病风险降低干预的试点研究。
可行性和实施的潜力,我们建议在一个综合的医疗保健系统中进行我们的试验。
输送系统。此外,我们计划利用个性化干预,这在治疗中已被证明是成功的。
用于管理抑郁症和高血压等疾病的医疗保健环境,
风险因素的最大变化。具体来说,我们建议随机选择200名高危老年人(年龄≥70岁
有主观认知主诉,认知测试表现在正常下限,≥ 2
可改变的风险因素,将有针对性的干预),以两年的多领域阿尔茨海默氏症的风险
减少研究(MARRS)干预或健康教育(HE)对照。在MARRS干预组中,
该小组将与参与者合作,制定个性化的行动计划,以解决风险降低问题,包括
心血管风险管理;戒烟;身体、精神和社会活动;健康饮食;
改善睡眠质量和药物管理。我们研究的目标是收集关于
与HE相比,MARRS对2年认知能力下降率的影响(目的1);比较阿尔茨海默病患者的变化
可改变的风险因素(目标2);并收集关于MARRS与HE对其他
重要的健康相关结果(目标3)。我们还将比较识别高风险患者的策略
这一点和未来的研究。这项创新的试点试验将提供急需的信息,以支持未来
多地点试验,最终目标是延缓或预防导致阿尔茨海默病的认知能力下降。
英文摘要
Alzheimer's disease prevalence is expected to triple by 2050, and current medications do not change the
disease course. However, recent studies have projected that up to 30% of Alzheimer's disease may be
preventable by targeting modifiable risk factors. Indeed, population-based studies are finding that, although the
total number of dementia cases is growing, age-specific incidence rates are declining in parallel with
population-level reductions in risk factors such as low education, smoking and cardiovascular disease.
Furthermore, studies in Europe have demonstrated slower cognitive decline and less cognitive impairment with
multi-domain risk reduction interventions. Given the importance of Alzheimer's prevention and the potential
benefits of risk reduction for general as well as brain health, even relatively small reductions in Alzheimer's
incidence would have a dramatic public health impact. Despite the tremendous promise of the multi-domain
risk reduction approach, no primary prevention trials have been performed in the U.S. We propose to conduct
a pilot study of a multi-domain Alzheimer's disease risk reduction intervention in the U.S. To maximize
feasibility and the potential for implementation, we propose to perform our trial within an integrated healthcare
delivery system. In addition, we plan to utilize a personalized intervention, which has proven successful in the
healthcare setting for managing conditions such as depression and hypertension, and which should yield
greatest change on risk factors. Specifically, we propose to randomize 200 higher-risk older adults (age ≥70
with subjective cognitive complaints, performance in the lower end of normal on a cognitive test and ≥ 2
modifiable risk factors that will be targeted by our intervention) to a two year Multi-domain Alzheimer's Risk
Reduction Study (MARRS) intervention or a Health Education (HE) control. In the MARRS intervention group,
the team will work with participants to develop a personalized action plan to address risk reduction including
cardiovascular risk management; smoking cessation; physical, mental and social activity; healthy diet;
improved sleep quality and medication management. The goals of our study are to collect pilot data on the
effect of MARRS on 2-year rate of cognitive decline compared to HE (Aim 1); compare changes in Alzheimer's
modifiable risk factors (Aim 2); and gather preliminary data on the effect of MARRS versus HE on other
important health-related outcomes (Aim 3). We will also compare strategies for identifying higher-risk patients
for this and future studies. This innovative pilot trial will provide critically needed information to support a future
multi-site trial, with the ultimate goal of delaying or preventing cognitive decline leading to Alzheimer's disease.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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海外基金