A TRIAL OF TTP488 TO SLOW THE RATE OF CLINICAL PROGRESSION OF PATIENTS WITH AD

TTP488 减缓 AD 患者临床进展速度的试验

基本信息

项目摘要

Project 3: A Trial of TTP488 to Slow the Rate of Clinical Progression of Patients with AD Currently FDA-approved drugs for Alzheimer's disease (AD) are primarily symptomatic and do not target pathogenic pathways. Deposition of amyloid beta protein (Ali) in plaques and inflammation may offer therapeutic targets. The receptor for advanced glycation endproducts (RAGE) is expressed in neurons and astrocytes and is upregulated in AD. RAGE interacts with multiple ligands, including AIJ, and may link AS to inflammation and neuronal dysfunction. Inhibition of RAGE/ligand interactions may slow the progression of neuropathological defects and cognitive changes induced by AH. TTP488 is a small molecule identified by a screening process, that binds to RAGE in vitro, and inhibits the interaction of RAGE with its ligands. In vivo, TTP488 crosses the blood brain barrier and, in transgenic mouse AD models, reduces brain amyloid load and behavioral dysfunction. The compound is well tolerated in healthy human subjects, including daily oral dosing for 1 month in elderly subjects, and longer safety studies in patients with AD are ongoing (data available in February 2006). We propose to carry out a randomized, double blind, multicenter trial in 350 patients with mild to moderate AD treated with one dose of TTP488 or placebo for 18 months. Subjects will be randomized 60:40 to receive active drug or placebo. The hypothesis is that treatment with TTP488, relative to placebo, will lead to slower clinical decline. Subjects will be followed at regular intervals to assess cognition, function, behavior, safety and tolerability. Primary outcome measures are the ADAS-cog and CDR Sum of Boxes (CDR-SOB). Secondary outcome measures are the ADCS-ADL and Neuropsychiatric Inventory (NPI). Drug levels and biomarkers will be measured in plasma. Standard therapy for AD will be permitted. The study has 90% power to detect a 41% or larger change on the ADAS-cog assuming a 3.8 point mean annual change in the placebo group, and has 80% power to detect a 35% change.
项目3:TTP488减缓AD患者临床进展速度的试验

项目成果

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DOUGLAS R GALASKO其他文献

DOUGLAS R GALASKO的其他文献

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{{ truncateString('DOUGLAS R GALASKO', 18)}}的其他基金

A Single Ascending Dose / Multiple Ascending Dose Phase I study of the GSM 776890 in healthy normal subjects
健康正常受试者中 GSM 776890 的单次递增剂量/多次递增剂量 I 期研究
  • 批准号:
    10335246
  • 财政年份:
    2021
  • 资助金额:
    $ 154.31万
  • 项目类别:
Clinical Core
临床核心
  • 批准号:
    10407979
  • 财政年份:
    2019
  • 资助金额:
    $ 154.31万
  • 项目类别:
Clinical Core
临床核心
  • 批准号:
    10615163
  • 财政年份:
    2019
  • 资助金额:
    $ 154.31万
  • 项目类别:
Comparative Study of Molecular Signatures in HIV-Related Neuropathogenesis and Alzheimer's Disease
HIV 相关神经发病机制和阿尔茨海默氏病分子特征的比较研究
  • 批准号:
    10407966
  • 财政年份:
    2018
  • 资助金额:
    $ 154.31万
  • 项目类别:
Comparative Study of Molecular Signatures in HIV-Related Neuropathogenesis and Alzheimer's Disease
HIV 相关神经发病机制和阿尔茨海默氏病分子特征的比较研究
  • 批准号:
    10153614
  • 财政年份:
    2018
  • 资助金额:
    $ 154.31万
  • 项目类别:
Dementia with Lewy Bodies Consortium
路易体痴呆症联盟
  • 批准号:
    10673098
  • 财政年份:
    2016
  • 资助金额:
    $ 154.31万
  • 项目类别:
Dementia with Lewy Bodies Consortium
路易体痴呆症联盟
  • 批准号:
    10531287
  • 财政年份:
    2016
  • 资助金额:
    $ 154.31万
  • 项目类别:
Core A: Administrative Core
核心A:行政核心
  • 批准号:
    8676141
  • 财政年份:
    2014
  • 资助金额:
    $ 154.31万
  • 项目类别:
Clinical Core
临床核心
  • 批准号:
    8676142
  • 财政年份:
    2014
  • 资助金额:
    $ 154.31万
  • 项目类别:
Translational Center for Alzheimer's Disease Target and Drug Discovery
阿尔茨海默病靶点和药物发现转化中心
  • 批准号:
    8849662
  • 财政年份:
    2014
  • 资助金额:
    $ 154.31万
  • 项目类别:
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