HealthyNCT00505349
Blood Neurotrophic Factors in Adults
A study testing Computer-based cognitive training in people with Healthy, run by Posit Science Corporation at 1 site in United States.
Trial summary
The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Computer-based cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Phase 1
- 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
Show all 25Show fewer
- 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
- Phase 2
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94104
About this study
The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults.
Read the 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.
- Conditions
- Healthy
- Being tested
- Computer-based cognitive training
- Keywords
- neurotrophic factors, cognitive status, young adults, mature adults, cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based cognitive trainingBehavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| No Intervention Arm | No intervention | Phase I in this study will involve the evaluation of blood-derived neurotrophic factors in healthy, younger adults (18-30.) Individuals in this group will not undergo computerized, cognitive training. |
| Cognitive Training | Experimental | Phase II of this study will involve an evaluation of the pre- and post- cognitive training levels of blood-derived neurotrophic factors in healthy, mature adults. Participants randomized to this arm will receive SAAGE-based computerized cognitive training. Receives: Behavioral: Computer-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks post-enrollment
Secondary outcomes (1)
To obtain information on the levels of growth factors in health adults
Measured: Required blood draws at three study intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Henry Mahncke, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505349
- Sponsor's protocol ID
- OUT-117-2005
- Status last verified
- Feb 2016
- First submitted
- 19 Jul 2007
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Neurotrophic Factors in Adults
- ClinicalTrials.gov ID
- NCT00505349
- Acronym / sponsor ID
- OUT-117-2005
- Conditions
- Healthy
- Keywords
- neurotrophic factors, cognitive status, young adults, mature adults, cognitive training
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, Case Western Reserve University
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention Arm | No intervention | –Phase I in this study will involve the evaluation of blood-derived neurotrophic factors in healthy, younger adults (18-30.) Individuals in this group will not undergo computerized, cognitive training. |
| Cognitive Training | Experimental | Behavioral: Computer-based cognitive trainingPhase II of this study will involve an evaluation of the pre- and post- cognitive training levels of blood-derived neurotrophic factors in healthy, mature adults. Participants randomized to this arm will receive SAAGE-based computerized cognitive training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Phase 1: Closed
- Age 18-30 at the time of consent
- Good general medical health
- Willing to undergo venipuncture procedure
- Phase 2: Activation Pending
Key exclusion criteria (25 listed)
- Phase 1
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based cognitive trainingThe 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.) | Behavioural | Cognitive Training |
Primary outcome
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
1 secondary outcome
To obtain information on the levels of growth factors in health adults
Time frame: Required blood draws at three study intervals
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Mahncke, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based cognitive training in people with Healthy, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.