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

基本信息

  • 批准号:
    9786200
  • 负责人:
  • 金额:
    $ 873.25万
  • 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 2025-05-31
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY This is a multi-PI application for an R01 award under PAR-18-513. The proposed project titled “Combination Anti-Amyloid Therapy in Preclinical Alzheimer's Disease” is a multicenter randomized placebo-controlled two arm clinical trial of a combination anti-amyloid therapy: an anti-fibrillar amyloid antibody for the initial 18 months combined with BACE inhibition therapy for 4 years, in preclinical AD, defined as asymptomatic individuals with elevated brain amyloid as determined by florbetapir PET scanning. The primary outcome will be a cognitive composite (a modified version of the Preclinical Alzheimer's Cognitive Composite, PACC5), with functional and clinical assessments along with volumetric MR and tau PET as secondary outcomes (and, in a subset, CSF biomarkers). The specific Aims of the proposed study are; 1. to evaluate the impact of a combination anti-amyloid regimen on fibrillar amyloid in brain as indicated by amyloid PET SUVr, 2. to evaluate the efficacy and safety of a combination anti-amyloid regimen in individuals with preclinical AD, and 3. to evaluate the impact of the combination anti-amyloid regimen on AD biomarkers. Drs. Sperling and Aisen will share responsibility for scientific oversight of the clinical design and execution of the study and Imaging oversight will be provided by Dr. Johnson. The ACTC will provide the administrative and operational support, data capture and data management, clinical monitoring and site management, safety oversight, biostatistical support, and biomarker sample processing storage and support. Final selection of therapeutic agents for this trial will be made by a compound selection committee composed of field experts. Committee membership will include external experts in AD drug development and AD neurobiology, appointed in concert with NIA. The study team will work collaboratively with the pharmaceutical company researchers who have clinical experience with these therapeutics in development. This will be the first study of its kind: a potentially synergistic combination approach to dramatically reducing amyloid from asymptomatic individuals on the AD spectrum. Combination therapy trials are increasingly proposed by investigators and regulators to improve the likelihood of success in trials aiming for disease-modification. This approach could ultimately prevent the onset of AD symptoms
项目总结

项目成果

期刊论文数量(0)
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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
The Development of Anti-Amyloid Therapy for Alzheimer’s Disease
  • DOI:
    10.2165/00023210-200519120-00002
  • 发表时间:
    2005-01-01
  • 期刊:
  • 影响因子:
    7.400
  • 作者:
    Paul S. Aisen
  • 通讯作者:
    Paul S. Aisen
Randomised controlled trials for the prevention of cognitive decline or dementia: A systematic review
  • DOI:
    10.1016/j.arr.2022.101777
  • 发表时间:
    2022-12-01
  • 期刊:
  • 影响因子:
    12.400
  • 作者:
    Nicola Coley;Caroline Giulioli;Paul S. Aisen;Bruno Vellas;Sandrine Andrieu
  • 通讯作者:
    Sandrine Andrieu

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:
    $ 873.25万
  • 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:
    $ 873.25万
  • 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:
    $ 873.25万
  • 项目类别:
API A4 Alzheimer's Prevention Trial
API A4 阿尔茨海默病预防试验
  • 批准号:
    9768303
  • 财政年份:
    2018
  • 资助金额:
    $ 873.25万
  • 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:
    $ 873.25万
  • 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:
    $ 873.25万
  • 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:
    $ 873.25万
  • 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:
    $ 873.25万
  • 项目类别:
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
  • 批准号:
    9885998
  • 财政年份:
    2017
  • 资助金额:
    $ 873.25万
  • 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:
    $ 873.25万
  • 项目类别:

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