Blood Neurotrophic Factors in Adults
| Tracking Information | |||||
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| First Received Date ICMJE | July 19, 2007 | ||||
| Last Updated Date | May 15, 2013 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: Up to 14 weeks post-enrollment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
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. [ Time Frame: Up to 14 weeks post-enrollment ] | ||||
| Change History | Complete list of historical versions of study NCT00505349 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To obtain information on the levels of growth factors in health adults [ Time Frame: Required blood draws at three study intervals ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Blood Neurotrophic Factors in Adults | ||||
| Official Title ICMJE | Blood Neurotrophic Factors in Adults | ||||
| Brief Summary | The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Behavioral: Computer-based cognitive training
The experimental cognitive training program consists of interactive training exercises in which the participant responds to visual patterns and stimuli. The program is designed upon the principles of brain-plasticity, and, for the purposes of this study, is intended to be used for an 8-10 week period (40 total hours of training.) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Phase 1: Closed
Phase 2: Activation Pending
Exclusion Criteria: Phase 1
Phase 2 Sensory/Motor Exclusions:
Psychiatric Exclusions:
Neurological Exclusions:
Medication Exclusions:
Additional Exclusions:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00505349 | ||||
| Other Study ID Numbers ICMJE | OUT-117-2005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Posit Science Corporation | ||||
| Study Sponsor ICMJE | Posit Science Corporation | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Posit Science Corporation | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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