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临床试验/NCT00505349
NCT00505349撤回不适用

Blood Neurotrophic Factors in Adults

Posit Science Corporation2 个研究点 分布在 1 个国家开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
The primary outcome of this study will be the evaluation of blood derived neurotrophic factors in both young adults and in mature adults undergoing cognitive training.

研究概览

简要总结

The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults.

详细描述

Current research suggests that levels of brain-derived neurotrophic factor (BDNF) and certain excitatory neurotransmitters - specifically glutamate, D-serine, and glycine are low in participants with depression and other mental illnesses (Wolkowitz and Reus 2002, Tan et al., 2005; Shoval & Weizman, 2005; Hashimoto et al., 2005). Research also suggests that levels of both BDNF and excitatory transmitters can be enhanced by cognitive stimulation (Hynd et al., 2005; Wu et al., 2005; Yang et al., 2005; Mattson et al., 2004). BDNF is found in brain tissue and is also measurable in blood; it stimulates neuronal cell growth in certain brain regions (Duman, 2004). In Phase 1, we wish to measure the levels of specific neurotrophic factors in healthy, young participants. Phase 2 is intended to correlate similar levels with change in neurocognitive performance in healthy, older participants. Overall, this study is designed to obtain a raw measure of the impact that cognitive training has on the mature adult brain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Phase 1: Closed
  • Age 18-30 at the time of consent
  • Good general medical health
  • Willing to undergo venipuncture procedure
  • Phase 2: Activation Pending
  • Age 65 or older at the time of consent
  • Mini-Mental Status Examination (MMSE) score of 26 or higher
  • Willing to undergo venipuncture procedure
  • Fluency in the English language
  • Participant is willing and able to commit to the time requirement of the study

排除标准

  • Participant is experiencing chronic or acute illness
  • Current substance abuse, including alcoholism
  • Diagnosis of a major psychological disorder
  • Current use, or use within the past 3 months of medications specified by protocol
  • Participant is unwilling or unable to perform questionnaires as specified in the protocol
  • Participant is not capable of giving informed consent or is unable to comprehend and/or follow directions in English
  • Participant is enrolled in a concurrent clinical study that could affect the outcome of this study
  • Female only: Participant is pregnant
  • Sensory/Motor Exclusions:
  • Reported or observed difficulties with a participant's dominant hand
  • Psychiatric Exclusions:
  • Current diagnosis of a major psychological disorder or a psychiatric hospitalization
  • Current substance abuse, including alcoholism
  • Neurological Exclusions:
  • Current diagnosis of a major neurological disorder that may impact cognitive functioning
  • History of stroke, traumatic brain injury (leading to loss of consciousness), brain cancer, or invasive neurological procedure within the past year
  • Diagnosis of medically uncontrolled seizure disorder
  • Medication Exclusions:
  • Current use, or use within the past 3 months of medications specified within the investigational plan
  • Additional Exclusions:
  • Participant is unwilling or unable to perform assessments and/or evaluations as specified in the protocol
  • Participant is not capable of giving informed consent or is unable to comprehend and/or follow directions
  • Participant is enrolled in a concurrent clinical study that could affect the outcome of this study

结局指标

主要结局

The primary outcome of this study will be the evaluation of blood derived neurotrophic factors in both young adults and in mature adults undergoing cognitive training.

时间窗: Up to 14 weeks post-enrollment

次要结局

  • To obtain information on the levels of growth factors in health adults(Required blood draws at three study intervals)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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