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A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimerʼs Disease

A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimerʼs Disease
一项旨在评估 CT1812 治疗对轻度至中度阿尔茨海默病受试者突触活动影响的脑电图 (EEG) 试验研究
批准号:
10651320
负责人:
ANTHONY O CAGGIANO
金额:
$214.44万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-07-01 至 2023-11-30

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中文摘要
翻译
摘要。认知治疗公司(cognitive Therapeutics, Inc., CogRx)正在开发一种疾病改善药物ElaytaTM (CT1812)
英文摘要
ABSTRACT. Cognition Therapeutics, Inc. (CogRx) is developing ElaytaTM (CT1812), a disease-modifying drug for Alzheimer’s disease (AD). CT1812 is the first highly brain penetrant selective sigma-2 receptor antagonist small molecule. This first-in-class drug candidate selectively displaces amyloid-β oligomers bound to neuronal receptors at synapses and protects synapses from toxic oligomer effects, clearing them from the brain into the cerebrospinal fluid (CSF). When administered once daily for 28 days to mild to moderate AD patients, CT1812 significantly reduces concentrations of synaptic degeneration markers in AD patient CSF. Based on our review of publicly-disclosed clinical trial data, no other therapeutic currently in development selectively targets the most toxic form of the Aβ protein – oligomers. No other AD drug candidate reduces synaptic damage markers as much, and as rapidly, as CT1812 in Alzheimer's patients. Our Aim in the proposed trial is to identify non-invasive measures to quantify the CNS impact of CT1812 demonstrated ability to reduce synaptic damage in AD patients. This pilot trial project proposes to evaluate the effect of one month of CT1812 treatment on quantitative EEG in a Phase 1b randomized double-blind, placebo-controlled, crossover clinical trial in AD patients. We hypothesize that the rapid reduction in synaptic damage CSF biomarkers seen in previous clinical trials will be accompanied by a reduction in global theta power and provide information on the suitability of this sensitive non-invasive qEEG method of measuring synaptic function for measuring patient response to drug treatment in future efficacy studies. Completion of this pilot study in AD patients will inform the design and methods of the subsequent Phase 2a proof of concept trials with CT1812.
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies
  • 批准号:
    10674687
  • 项目类别:
  • 资助金额:
    $847.91万
  • 财政年份:
    2021
  • 负责人:
    ANTHONY O CAGGIANO
  • 依托单位:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies
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    10187183
  • 项目类别:
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    $1076.47万
  • 财政年份:
    2021
  • 负责人:
    ANTHONY O CAGGIANO
  • 依托单位:
Human AME study of CT1812, a small molecule in phase 2 clinical trials for the treatment of Alzheimer's disease
  • 批准号:
    10247968
  • 项目类别:
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    $164.28万
  • 财政年份:
    2021
  • 负责人:
    ANTHONY O CAGGIANO
  • 依托单位:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies
  • 批准号:
    10402396
  • 项目类别:
  • 资助金额:
    $1025.43万
  • 财政年份:
    2021
  • 负责人:
    ANTHONY O CAGGIANO
  • 依托单位:
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  • 项目类别:
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