Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease
临床前/前驱阿尔茨海默病的试验就绪队列
基本信息
- 批准号:9885998
- 负责人:
- 金额:$ 492.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-05-01 至 2023-04-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAlgorithmsAlzheimer disease screeningAlzheimer&aposs DiseaseAlzheimer&aposs disease pathologyAlzheimer’s disease biomarkerAmericanAmyloidAmyloid beta-42Amyloid beta-ProteinBiological AssayBiological MarkersBrainClinicalClinical ResearchClinical TrialsClinical assessmentsCognitiveCollaborationsCollectionCommunitiesConsensusConsentCountryDataData CollectionDementiaDevelopmentDiseaseEarly intervention trialsEligibility DeterminationEnrollmentFreezingFutureGeneticGoalsHome environmentImmunoassayImmunoprecipitationImpaired cognitionIndividualInsuranceInternetInterventionLifeMass Spectrum AnalysisMeasurementMeasuresMedicalMethodsNerve DegenerationNeurobiologyObservational StudyOnline SystemsOutcome MeasureParticipantPathologyPathway interactionsPerformancePersonsPharmacy facilityPlasmaPositron-Emission TomographyPrevention trialProcessProcess AssessmentProgram DevelopmentRegistriesReportingRiskSamplingScientistSecondary PreventionSensitivity and SpecificitySeriesShipsSiteSpecimenSpinal PunctureStatistical AlgorithmStreamSystemTechnologyTestingTimeTimeLineTravelValidationWorkapolipoprotein E-4basecandidate selectionclinical biomarkersclinical research sitecognitive functioncognitive performancecognitive testingcohortcostdata registrydemographicsdrug developmentexperiencefollow-upfunctional outcomeshealth care settingshealth datahigh riskimprovedinnovationinterestmild cognitive impairmentneuroimagingnon-dementednovelpre-clinicalprodromal Alzheimer&aposs diseaserecruittau Proteinstool
项目摘要
Project Summary
Based on growing recognition that the long pre-dementia stages of Alzheimer's disease (AD) represent the
optimal time for interventions aimed at modifying the neurobiology of the disease, most recent drug development
programs enroll participants at the preclinical/asymptomatic and prodromal/mild cognitive impairment stages.
However, the timeframe, complexity and expense of the recruitment process and site activation for these
secondary prevention trials are extremely challenging, and indeed site start-up and trial enrollment, in general,
represent the greatest bottleneck for drug development for AD. Thus, there is growing consensus in our field that
we must fundamentally overhaul the current clinical trial recruitment and assessment process for these early
intervention trials. The overarching goal of this proposal is to accelerate current and future secondary prevention
trial enrollment through an innovative, highly efficient approach to identify, evaluate, and enroll appropriate
preclinical and prodromal trial candidates, supported by a new site network with enhanced capacities for more
efficient and effective conduct of AD clinical trials. The specific goal of the current project is to build a large trial-
ready cohort (TRC) for preclinical/prodromal AD (PAD) trials (TRC-PAD). TRC-PAD (n=2000; 1000
preclinical/1000 prodromal AD) will facilitate enrollment into ongoing PAD trials using the ACTC framework. This
application describes a process of connecting existing “feeder” registries and studies to a web based Registry to
capture demographic, genetic and longitudinal clinical and cognitive information on older, non-demented
individuals interested in trials. The Registry data generates risk scores for AD pathology (initially elevated
amyloid in brain, but with methods adaptable to tau pathology and other biomarkers), that allows efficient
selection of candidates for in-person biomarker (initially amyloid PET scans) and clinical assessment. The
results of these assessments, in turn, allow an adaptive statistical algorithm to improve the selection process
moving forward. Individuals with PET scans showing amyloid accumulation in brain (or alternative biomarker
confirmation) are invited to join with semi-annual in-person follow-up within the network of pre-qualified clinical
sites, from which they can be invited to enroll in early stage trials. Overall, the process will dramatically shorten
the timeline for preclinical/prodromal trials, and will address a series of scientific hypotheses to guide further
development in the field.
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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Paul S. Aisen其他文献
Poster Number: EI 19 - Association of Subjective Cognitive Complaints and Objective Cognitive Impairment in Late Life Depression
- DOI:
10.1016/j.jagp.2018.01.110 - 发表时间:
2018-03-01 - 期刊:
- 影响因子:
- 作者:
Ruth Morin;David D. Bickford;Yiu Ho Au;Kelly B. Scherer;Daniel C. Catalinotto;Philip Insel;Duygu Tosun;Michelle Zmuda;Arthur W. Toga;Paul S. Aisen;Rema Raman;Andrew Saykin;Michael Weiner;Meryl A. Butters;Craig Nelson;Scott Mackin - 通讯作者:
Scott Mackin
NAP ameliorates Alzheimer’s pathology in ad model mouse
- DOI:
10.1016/j.npep.2006.09.022 - 发表时间:
2006-12-01 - 期刊:
- 影响因子:
- 作者:
Y. Matsuoka;Illana Gozes;Paul S. Aisen - 通讯作者:
Paul S. Aisen
Paul S. Aisen的其他文献
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{{ truncateString('Paul S. Aisen', 18)}}的其他基金
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study
无症状阿尔茨海默病 (A4) 开放标签扩展研究中的抗淀粉样蛋白治疗
- 批准号:
10554282 - 财政年份:2019
- 资助金额:
$ 492.96万 - 项目类别:
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study
无症状阿尔茨海默病 (A4) 开放标签扩展研究中的抗淀粉样蛋白治疗
- 批准号:
10358480 - 财政年份:2019
- 资助金额:
$ 492.96万 - 项目类别:
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study
无症状阿尔茨海默病 (A4) 开放标签扩展研究中的抗淀粉样蛋白治疗
- 批准号:
9930020 - 财政年份:2019
- 资助金额:
$ 492.96万 - 项目类别:
Combination anti-amyloid therapy for preclinical Alzheimer's disease
临床前阿尔茨海默病的抗淀粉样蛋白联合治疗
- 批准号:
9786200 - 财政年份:2018
- 资助金额:
$ 492.96万 - 项目类别:
Combination anti-amyloid therapy for preclinical Alzheimer's disease
临床前阿尔茨海默病的抗淀粉样蛋白联合治疗
- 批准号:
10452475 - 财政年份:2018
- 资助金额:
$ 492.96万 - 项目类别:
Combination anti-amyloid therapy for preclinical Alzheimer's disease
临床前阿尔茨海默病的抗淀粉样蛋白联合治疗
- 批准号:
10666411 - 财政年份:2018
- 资助金额:
$ 492.96万 - 项目类别:
Alzheimer's Clinical Trials Consortium (ACTC)
阿尔茨海默病临床试验联盟 (ACTC)
- 批准号:
10435786 - 财政年份:2017
- 资助金额:
$ 492.96万 - 项目类别:
Alzheimers Clinical Trials Consortium (ACTC)
阿尔茨海默病临床试验联盟 (ACTC)
- 批准号:
9753042 - 财政年份:2017
- 资助金额:
$ 492.96万 - 项目类别:
Alzheimer's Clinical Trials Consortium (ACTC)
阿尔茨海默病临床试验联盟 (ACTC)
- 批准号:
10719531 - 财政年份:2017
- 资助金额:
$ 492.96万 - 项目类别:
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