课题基金 / 基金详情

PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health

PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health
PhytoSERM 针对更年期潮热和持续大脑健康
批准号:
10547639
负责人:
ROBERTA EILEEN BRINTON
金额:
$133.74万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-09-30 至 2024-08-31
关键词:
AddressAgeAgingAlternative HealthAlzheimer&aposs DiseaseAlzheimer&aposs disease modelAlzheimer&aposs disease related dementiaAlzheimer&aposs disease riskAlzheimer’s disease biomarkerAnimal ModelBiological MarkersBloodBody CompositionBone DensityBrainBreastBreast Cancer Risk FactorCellsChronicClinicalClinical ResearchClinical TrialsCognitionCognitiveDevelopmentDiseaseDoseDouble-Blind MethodDrug KineticsElderlyEndocrineEstrogen Receptor betaEstrogen TherapyEstrogensExhibitsFemaleFormulationFrequenciesFrightGenisteinGenotypeGlucoseGoalsHealthHormonesHot flushesInflammatoryInterventionIsoflavonesLegal patentLifeMammary Gland ParenchymaMenopausal SymptomMenopauseMetabolicMetabolismMitochondriaModelingNational Institute on AgingNeurologicNeuronal PlasticityNeurosecretory SystemsNight SweatingOutcomeParticipantPathologyPerimenopausePersonal SatisfactionPhasePhenotypePhytoestrogensPlantsPostmenopausePrevention strategyProtein IsoformsResearchResearch SupportRiskRodent DiseasesSafetySelective Estrogen Receptor ModulatorsSeveritiesSleep disturbancesSmall Business Innovation Research GrantSymptomsTherapeuticTherapy Clinical TrialsTimeTissuesToxic effectTranslatingTranslationsUterusVasomotorWomanWomen&aposs Healthage relatedagedassociated symptombaseblood-based biomarkerbrain healthclinical developmentcognitive functioncritical perioddaidzeineffective interventioneffective therapyequolestrogenichormone therapyinnovationlifetime risklipidomicsmalignant breast neoplasmmiddle agemortalityneuronal survivalneurotoxicityopen labeloral supplementationpharmacokinetics and pharmacodynamicspre-clinicalprecision medicinepreventrandomized placebo-controlled clinical trialrational designreproductiveresponsesafety and feasibilitysoytreatment strategy

项目摘要

项目成果

ROBERTA EILEEN BRINTON的其他基金

相似基金

相关文献

中文摘要
翻译
项目总结/文摘
英文摘要
PROJECT SUMMARY/ABSTRACT Women are at greater life-time risk for Alzheimer’s disease (AD). One potential factor contributing to greater life-time risk of AD is the midlife menopausal endocrine aging transition when multiple AD risk conditions can emerge and which are consistent with prodromal / preclinical features of the disease. While estrogen or hormone therapy administered when menopausal women are symptomatic could reduce risk of AD, the fear of breast cancer leads many women to forego this approach. An innovative alternative to estrogen therapy is to target estrogen action in brain while avoiding estrogen-associated proliferation in breast tissue. To achieve that goal, we propose Phase 2 clinical development of “PhytoSERM”, a selective estrogen receptor beta (ERß) modulator that promotes estrogenic action through ERß in brain while inhibitory in reproductive tissue. PhytoSERM is a rationally designed formulation of 3 phytoestrogens (each are Generally Recognized as Safe by the FDA). Our earlier NIA supported PhytoSERM Phase 1b/2a clinical trial determined that PhytoSERM was safe and well-tolerated, exhibited predictive pharmacokinetics in peri- and postmenopausal women and identified responder phenotype (https://clinicaltrials.gov/ct2/show/NCT01723917). Proposed herein is a Phase 2, double-blind, parallel-group, randomized, placebo-controlled clinical trial with an open-label extension to determine efficacy of PhytoSERM in symptomatic peri- and post-menopausal women. Primary objectives are to determine the efficacy of PhytoSERM to alleviate menopausal symptoms, mainly hot flashes. Secondary objectives are to evaluate the effect of PhytoSERM on: 1) cognitive function, 2) sleep disturbances, and 3) non-neurologic menopausal symptoms, including bone mineral density and body composition. Tertiary objectives are to determine impact of PhytoSERM on blood-based AD biomarkers. This Phase 2 PhytoSERM clinical trial addresses multiple strategic directions of the National Institutes on Aging’s 2020-2025: Aging Well in the 21st Century ref Specifically, Goal C-3 to: “Develop effective interventions to maintain health, well-being, and function and prevent or reduce the burden of age-related diseases” and “Conduct clinical studies / translation of new interventions to the clinical setting.” Goal D-4: Translate basic discovery into effective treatment and/or prevention strategies for AD/ADRD and” Goal F-4: Support research on women’s health.” PhytoSERM clinical trial also contributes to achieving the National Alzheimer’s Disease Project Act (NAPA) to effectively prevent and treat AD by 2025 Goal 1B. PhytoSERM addresses a critical unmet need in women’s health to reduce risk of Alzheimer’s in later life.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Translational Research in Alzheimer's Disease and related Dementias (TRADD)
  • 批准号:
    10709167
  • 项目类别:
  • 资助金额:
    $29.45万
  • 财政年份:
    2023
  • 负责人:
    ROBERTA EILEEN BRINTON
  • 依托单位:
Novel Intranasal Formulations of Allopregnanolone, a Regenerative Therapeutic for Alzheimer's Disease
  • 批准号:
    10698555
  • 项目类别:
  • 资助金额:
    $50.58万
  • 财政年份:
    2023
  • 负责人:
    ROBERTA EILEEN BRINTON
  • 依托单位:
PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
  • 批准号:
    10560591
  • 项目类别:
  • 资助金额:
    $154.45万
  • 财政年份:
    2022
  • 负责人:
    ROBERTA EILEEN BRINTON
  • 依托单位:
PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
  • 批准号:
    10344556
  • 项目类别:
  • 资助金额:
    $212.12万
  • 财政年份:
    2022
  • 负责人:
    ROBERTA EILEEN BRINTON
  • 依托单位:
国内基金
海外基金
补阳还五汤通过AGE-RAGE通路调控脓毒症免疫失衡的机制与转化研究
靶向递送一氧化碳调控AGE-RAGE级联反应促进糖尿病创面愈合研究
  • 批准号:
    JCZRQN202500010
  • 项目类别:
    省市级项目
  • 资助金额:
    --
  • 批准年份:
    2025
  • 负责人:
  • 依托单位:
对香豆酸抑制AGE-RAGE-Ang-1通路改善海马血管生成障碍发挥抗阿尔兹海默病作用
  • 批准号:
    2025JJ70209
  • 项目类别:
    省市级项目
  • 资助金额:
    --
  • 批准年份:
    2025
  • 负责人:
    雷芬芳
  • 依托单位:
AGE-RAGE通路调控慢性胰腺炎纤维化进程的作用及分子机制
  • 批准号:
    --
  • 项目类别:
    面上项目
  • 资助金额:
    --
  • 批准年份:
    2024
  • 负责人:
    万荣
  • 依托单位: