Novel automated performance-based ADL outcomes for early AD clinical trials
用于早期 AD 临床试验的基于性能的新型自动化 ADL 结果
基本信息
- 批准号:10370360
- 负责人:
- 金额:$ 64.18万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-06-01 至 2025-02-28
- 项目状态:未结题
- 来源:
- 关键词:Activities of Daily LivingAlzheimer&aposs DiseaseAlzheimer&aposs disease pathologyAlzheimer’s disease biomarkerAmyloidAtrophicBehavioralBiological MarkersCaregiver BurdenCaregiversCellular PhoneClinicalClinical TrialsClinical dementia rating scaleCognitionCognitiveCommunicationCompanionsComplexComputersDataDementiaDepositionDetectionDiseaseDisease ProgressionEarly DiagnosisEarly treatmentElderlyFundingGoalsHealth InsuranceImageImpaired cognitionImpairmentIndividualInferiorInternetKnowledgeLifeMagnetic Resonance ImagingMeasuresMedicalMemoryNorth AmericaOutcomeOutcome MeasureParietalPatientsPerformancePhysiciansPittsburgh Compound-BPositron-Emission TomographyPrevention trialPrimary Care PhysicianResearchSamplingSecondary PreventionSourceSumSymptomsSystemTechnologyTelephoneTestingThickTimeTracerUnited States Food and Drug AdministrationUniversitiesVisualizationVoiceamnestic mild cognitive impairmentclinical outcome measurescognitive functiondesignentorhinal cortexexecutive functionfunctional declineimaging biomarkerimprovedin vivoinstrumentinstrumental activity of daily livingmild cognitive impairmentmolecular imagingnovelpaymentpre-clinicalprodromal Alzheimer&aposs diseaserecruitregional atrophyresponsetau Proteinsβ-amyloid burden
项目摘要
Project Summary
Impairment in activities of daily living (ADL) is a hallmark of Alzheimer’s disease (AD) dementia
and a major source of caregiver burden. Similar to cognitive and behavioral changes in AD, subtle
difficulties in complex ADL may begin even before the stage of amnestic mild cognitive
impairment (MCI). Preclinical AD consists of individuals with minimal or no symptoms but
biomarker evidence of AD pathology. As secondary prevention trials in preclinical AD are being
launched and the FDA is providing new guidance for early AD trial outcomes, it is imperative that
we develop new ecologically valid instruments to detect subtle yet clinically meaningful
alterations in complex ADL. Older individuals are increasingly required to interact via
telephone and computer-based technology to perform essential ADL. The overall goal of this
proposal is to optimize and validate a novel set of automated performance-based ADL instruments,
the Harvard Automated Phone Task (APT) and computer- based Czaja Functional Assessment
Battery (CFAB), which have been designed to tap the high level tasks that challenge seniors in
daily life and to serve as ADL outcomes for preclinical and early prodromal AD clinical trials. For
the first time, we have a chance to visualize regional tau deposition in vivo, using a new
promising positron emission tomography (PET) tracer, T807, a.k.a. 18F-AV-1451. 1) To
date, there have been no consistent associations between ADL performance and AD biomarkers in
clinically normal (CN) elderly or early MCI alone. 2) We now have a unique opportunity to relate
novel molecular imaging biomarkers of tau and amyloid to our novel ADL instruments. 3) There are no
established instruments for detecting early ADL changes in CN individuals who may be in the
preclinical stages of AD or in individuals with early prodromal AD. Here we seek
to fill this gap in knowledge by further validating the Harvard APT and CFAB.
The telephone is still the most prevalent technology mode of communication in the elderly, nearly
all of whom in North America own a phone; about a third own a computer; more are starting to use
smartphones; and most need to use an interactive voice response system (IVRS) to complete everyday
activities. In the Harvard APT, subjects navigate an IVRS in order to refill a prescription
(APT-Script), select a new physician (APT-PCP), and make a bank account transfer and payment
(APT-Bank). In the CFAB, subjects refill a prescription (CFAB-Script) and perform automated teller
machine (ATM) transactions (CFAB-ATM). These tasks simulate real-life activities commonly required
of elderly. We will assess the Harvard APT and CFAB in 200 subjects (100 CN, 50 subjective
cognitive decline (SCD), and 50 MCI), assess their relationship to cognitive function at baseline
and over 3 years, assess their ability to track disease progression, and assess their relationship
to AD imaging biomarkers. We will leverage a unique well-characterized sample from other funded
studies to recruit the 100 CN subjects, who will already have imaging data and will only need to
undergo the novel ADL tests. The 100 SCD and MCI subjects will be newly recruited and will undergo
both clinical and imaging assessments.
项目摘要
日常生活活动能力(ADL)受损是阿尔茨海默病(AD)痴呆的一个标志
也是照顾者负担的主要来源。与AD的认知和行为变化相似,
复杂ADL的困难甚至可能在轻度认知遗忘阶段之前就开始开始
损害(MCI)。 临床前AD由具有最小症状或没有症状的个体组成,
AD病理学的生物标志物证据。由于临床前AD的二级预防试验正在进行,
FDA正在为早期AD试验结果提供新的指导,
我们开发了新的生态有效的仪器来检测微妙的但有临床意义的
复杂ADL的改变。 越来越多的老年人需要通过
电话和基于计算机技术来执行基本的ADL。这个项目的总体目标是
建议是优化和验证一套新的自动化的基于性能的ADL仪器,
哈佛自动电话任务(APT)和基于计算机的Czaja功能评估
电池(CFAB),旨在挖掘挑战老年人的高水平任务,
日常生活,并作为临床前和早期前驱AD临床试验的ADL结果。为
第一次,我们有机会在体内可视化区域tau沉积,使用新的
有前途的正电子发射断层扫描(PET)示踪剂,T807,又名 18F-AV-1451 1)到
迄今为止,ADL表现与AD生物标志物之间没有一致的相关性,
临床正常(CN)的老年人或单独的早期MCI。2)我们现在有一个独特的机会
tau蛋白和淀粉样蛋白的新型分子成像生物标志物与我们的新型ADL仪器。3)没有
已建立的用于检测CN个体早期ADL变化的工具,
在AD的临床前阶段或患有早期前驱AD的个体中。在这里我们寻求
通过进一步验证哈佛APT和CFAB来填补这一知识空白。
电话仍然是老年人最普遍的通信技术模式,
在北美,所有的人都拥有一部电话,大约三分之一的人拥有一台电脑,更多的人开始使用
智能手机;大多数人需要使用交互式语音应答系统(IVRS)来完成日常工作
活动在哈佛APT中,受试者导航IVRS以重新填充处方
(APT-Script),选择新医生(APT-PCP),并进行银行账户转账和付款
(APT-Bank).在CFAB中,受试者重新填写处方(CFAB脚本)并执行自动柜员机
自动柜员机(ATM)交易(CFAB-ATM)。这些任务模拟现实生活中的活动,
老年人。我们将在200名受试者中评估哈佛APT和CFAB(100名CN,50名主观
认知功能下降(SCD)和50 MCI),评估其与基线认知功能的关系
3年以上,评估他们跟踪疾病进展的能力,并评估他们之间的关系。
AD成像生物标志物。我们将利用其他资助的独特的特征鲜明的样本,
招募100名CN受试者的研究,这些受试者已经有成像数据,只需要
进行新的ADL测试。100名SCD和MCI受试者将是新招募的,
临床和影像学评估。
项目成果
期刊论文数量(4)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Measurement of Dimensions of Self-awareness of Memory Function and Their Association With Clinical Progression in Cognitively Normal Older Adults.
- DOI:10.1001/jamanetworkopen.2023.9964
- 发表时间:2023-04-03
- 期刊:
- 影响因子:13.8
- 作者:
- 通讯作者:
Associations of the Harvard Automated Phone Task and Alzheimer's Disease Pathology in Cognitively Normal Older Adults: Preliminary Findings.
- DOI:10.3233/jad-220885
- 发表时间:2023
- 期刊:
- 影响因子:0
- 作者:Gonzalez C;Mimmack KJ;Amariglio RE;Becker JA;Chhatwal JP;Fitzpatrick CD;Gatchel JR;Johnson KA;Katz ZS;Kuppe MK;Locascio JJ;Udeogu OJ;Papp KV;Premnath P;Properzi MJ;Rentz DM;Schultz AP;Sperling RA;Vannini P;Wang S;Marshall GA
- 通讯作者:Marshall GA
Depressive symptoms and hippocampal volume in autosomal dominant Alzheimer's disease.
常染色体显性阿尔茨海默病的抑郁症状和海马体积。
- DOI:10.1002/alz.13501
- 发表时间:2024
- 期刊:
- 影响因子:0
- 作者:Langella,Stephanie;Lopera,Francisco;Baena,Ana;Fox-Fuller,JoshuaT;Munera,Diana;Martinez,JairoE;Giudicessi,Averi;Vannini,Patrizia;Hanseeuw,BernardJ;Marshall,GadA;Quiroz,YakeelT;Gatchel,JenniferR
- 通讯作者:Gatchel,JenniferR
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GAD ASHER MARSHALL其他文献
GAD ASHER MARSHALL的其他文献
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{{ truncateString('GAD ASHER MARSHALL', 18)}}的其他基金
The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD
智能手机日常任务评估 (ASSET):针对早期 AD 的新 IADL 测试
- 批准号:
10081325 - 财政年份:2020
- 资助金额:
$ 64.18万 - 项目类别:
Neural Correlates of Apathy Across the Alzheimer's Disease Continuum
阿尔茨海默病连续体中冷漠的神经相关性
- 批准号:
9896450 - 财政年份:2020
- 资助金额:
$ 64.18万 - 项目类别:
Neural Correlates of Apathy Across the Alzheimer's Disease Continuum
阿尔茨海默病连续体中冷漠的神经相关性
- 批准号:
10336368 - 财政年份:2020
- 资助金额:
$ 64.18万 - 项目类别:
Novel automated performance-based ADL outcomes for early AD clinical trials
用于早期 AD 临床试验的基于性能的新型自动化 ADL 结果
- 批准号:
10116237 - 财政年份:2018
- 资助金额:
$ 64.18万 - 项目类别:
PIB binding, hypometabolism, apathy and executive dysfunction in MCI and AD
MCI 和 AD 中的 PIB 结合、代谢低下、冷漠和执行功能障碍
- 批准号:
8306143 - 财政年份:2009
- 资助金额:
$ 64.18万 - 项目类别:
PIB binding, hypometabolism, apathy and executive dysfunction in MCI and AD
MCI 和 AD 中的 PIB 结合、代谢低下、冷漠和执行功能障碍
- 批准号:
7939812 - 财政年份:2009
- 资助金额:
$ 64.18万 - 项目类别:
PIB binding, hypometabolism, apathy and executive dysfunction in MCI and AD
MCI 和 AD 中的 PIB 结合、代谢低下、冷漠和执行功能障碍
- 批准号:
8123387 - 财政年份:2009
- 资助金额:
$ 64.18万 - 项目类别:
PIB binding, hypometabolism, apathy and executive dysfunction in MCI and AD
MCI 和 AD 中的 PIB 结合、代谢低下、冷漠和执行功能障碍
- 批准号:
7790215 - 财政年份:2009
- 资助金额:
$ 64.18万 - 项目类别:
PIB binding, hypometabolism, apathy and executive dysfunction in MCI and AD
MCI 和 AD 中的 PIB 结合、代谢低下、冷漠和执行功能障碍
- 批准号:
8512631 - 财政年份:2009
- 资助金额:
$ 64.18万 - 项目类别:
THE EFFECTS OF DHA IN SLOWING THE PROGRESSION OF ALZHEIMER'S DISEASE
DHA 在减缓阿尔茨海默病进展方面的作用
- 批准号:
7719378 - 财政年份:2008
- 资助金额:
$ 64.18万 - 项目类别: