Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease
针对早期阿尔茨海默病认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
基本信息
- 批准号:10614897
- 负责人:
- 金额:$ 9.83万
- 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:2018-09-30 至 2023-04-30
- 项目状态:已结题
- 来源:
- 关键词:AcuteAdministrative SupplementAfrican American populationAgingAlzheimer&aposs DiseaseAlzheimer&aposs disease diagnosisAlzheimer&aposs disease pathologyAlzheimer&aposs disease related dementiaAlzheimer&aposs disease riskAmyloidAmyloid beta-ProteinAnabolismAnimalsBase of the BrainBehavior TherapyBehavioralBlack PopulationsBrainBrain regionBusinessesCaregiver BurdenCaringCertificationClinicalClinical ResearchClinical TrialsCognitiveCommunitiesDementiaDevelopmentDevicesDiseaseDisease ProgressionEarly InterventionEarly identificationEducational MaterialsEffectivenessEmotionalEnsureEntrepreneurshipEnvironmentEvaluationExposure toFunctional disorderFutureGenerationsGoalsGovernmentHealth care facilityHealthcareHippocampus (Brain)HomeHumanHuman Subject ResearchImpaired cognitionIndividualIndustryInternshipsInterventionIntervention StudiesIntervention TrialInvestigationKnowledgeLeadLeadershipMarketingMarylandMedicalMentorsMinorityMinority GroupsModificationMultimediaNeurosciencesOdorsOlfactory CortexOlfactory PathwaysParticipantPathologicPatient RecruitmentsPatientsPerformancePersonsPhasePhase II Clinical TrialsPhase III Clinical TrialsPlant RootsPlantsPoliciesPopulationPreventionPrimary Health CarePrincipal InvestigatorProcessProviderPsychophysicsPublic HealthRandomized Clinical TrialsRecommendationRecording of previous eventsRegimenResearchResearch PersonnelResourcesSafetySamplingSiteSleep disturbancesSmall Business Innovation Research GrantSmall Business Technology Transfer ResearchSolidStimulantStructureSystemTherapeuticTherapeutic InterventionTimeTrainingTraining ProgramsTranslatingTranslationsUnderrepresented MinorityUnited StatesUniversitiesUrsidae FamilyVisitabeta accumulationadvanced dementiaapolipoprotein E-4basecareercerebral atrophycognitive functioncognitive trainingcohortcomorbiditycomputerizedcostdistrustearly phase clinical trialeffectiveness implementation studyefficacy studyentorhinal cortexethnic minorityexperiencefeasibility trialfollow-uphabituationhands on researchhealth literacyimprovedinnovationintervention programmembermild cognitive impairmentminority communitiesminority studentneurofilamentnovelportabilitypreventpreventive interventionprogramsrecruitresearch and developmentresearch studyresiliencesatisfactionscreeningskillsskills trainingsocial stigmastimulant usesuccesstherapeutic targetuser-friendly
项目摘要
ABSTRACT
We propose to evaluate and optimize the portable, home-based product – the Computerized Olfactory Training
Program (COT) – as a disease modifying intervention for prevention of progressive cognitive decline and
progressive dementia in early Alzheimer's Disease (AD). The COT uses validated neuroprotective olfactory
stimulants to intensely engage the primary and secondary olfactory cortices, with stimulation parameters that
overcome olfactory habituation, paired with computerized olfactory cognitive training tasks that synergistically
enhance the same brain regions; with the goal of increasing structural and functional resilience to AD
progression. Phase I research and development met or exceeded stated technical milestones: COT
intervention led to increased olfactory and cognitive functions 6 and 12 months later in ApoE4 carriers with mild
cognitive impairment and early dementia. Among completers of 12-month follow-up visit, COT blunted
trajectory in shrinkage of the entorhinal cortex and the hippocampus. Furthermore, the acute effects of odorant
molecules in the COT in regulating sleep disruptions and emotional reactivity adds to a potential value of COT
for treatment of behavioral dysfunctions in advanced AD. Alzheimer’s disease is a major public health crisis
both in the United States and worldwide. Hitherto, no therapeutic has demonstrated significant effectiveness in
modifying progression from early stages to advanced stages of AD. Most putative disease modifying
therapeutics targeting various steps of amyloid biosynthesis and amyloid beta (Aβ) accumulation have either
failed to reverse cognitive decline or worsened cognitive decline in Phase III clinical trials. However,
neuroscience evidence that AD pathology progresses early, over several decades in the olfactory brain
regions, before emergence of progressive, irreversible cognitive decline and dementia, as well as experimental
and clinical findings that olfactory compromise accelerates the progression of AD, provide solid premise for
targeting olfactory structure and function in the modification of AD progression. The success of use of enriched
odor environment in reducing aggregation of pathological neurofilaments in animals spurred high hopes for
translation of olfactory training (OT) into treatment of AD in humans. Unfortunately, lack of innovative
approaches to sustain olfactory engagement sufficiently to influence functional and structural plasticity in
clinical populations, hindered the translation of OT into an AD intervention. We built an innovative olfactory
treatment delivery system for home use; established a proprietary regimen of safe neuroprotective plant
odorant extracts and stimulation parameters that overcome odorant habituation in the primary olfactory cortex;
and created a synchronized App to simultaneously administer olfactory cognitive training tasks that
synergistically target the same brain regions being stimulated by the odorants. This breakthrough product, the
COT showed excellent promise in reversing cognitive decline in our Phase I SBIR. Key technical objectives of
this Phase II project are to: (1) demonstrate COT efficacy for prevention of brain atrophy and cognitive decline
in a powered randomized clinical trial of early dementia; (2) validate its safety; (3) further configure the platform
for user-friendliness, portability for home use, acceptability and marketing; and (4) explore new indications for
treating behavioral disturbances in people with moderate to advanced dementia, in an effort to reduce care-
giver burden. Upon completion of Phase II, we will be poised to expand the research to Phase III efficacy
study, or an implementation study of effectiveness in the real-world setting through commercial partnerships
developed over the course of this project. To the best of our knowledge, this will be the first evaluation of a
home-based, scalable, computerized, chemosensory-based brain stimulation for disease modification in AD.
摘要
项目成果
期刊论文数量(0)
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Charles Chiedu Nwaokobia其他文献
Charles Chiedu Nwaokobia的其他文献
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{{ truncateString('Charles Chiedu Nwaokobia', 18)}}的其他基金
Development and Evaluation of Portable Compendium of Psychophysical and Physiological Tests for Alzheimer's Disease and Related Dementias (ADRD)
阿尔茨海默病和相关痴呆症(ADRD)便携式心理物理和生理测试纲要的开发和评估
- 批准号:
10699349 - 财政年份:2023
- 资助金额:
$ 9.83万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10794665 - 财政年份:2023
- 资助金额:
$ 9.83万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10741580 - 财政年份:2022
- 资助金额:
$ 9.83万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10469912 - 财政年份:2022
- 资助金额:
$ 9.83万 - 项目类别:
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
用于治疗疼痛的计算机化化学感应眼眶额网络训练 (CBOT-P) 的开发和评估
- 批准号:
10547925 - 财政年份:2022
- 资助金额:
$ 9.83万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10574428 - 财政年份:2018
- 资助金额:
$ 9.83万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10399659 - 财政年份:2018
- 资助金额:
$ 9.83万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10256329 - 财政年份:2018
- 资助金额:
$ 9.83万 - 项目类别:
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