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WithdrawnNCT00505349Updated Feb 5, 2016

Blood Neurotrophic Factors in Adults

An interventional study of Computer-based cognitive training in Healthy, sponsored by Posit Science Corporation. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-05.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • neurotrophic factors
  • cognitive status
  • young adults
  • mature adults
  • cognitive training
03

In context

Lead sponsor

Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    No Intervention Arm

    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.

  • Experimental
    Cognitive Training

    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.

    Behavioral: Computer-based cognitive training

Interventions

  • BehavioralComputer-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.)

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To obtain information on the levels of growth factors in health adults

    Time frame: Required blood draws at three study intervals

07

Study locations

1 site
  • Posit Science Corporation
    San Francisco, California 94104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00505349
Lead sponsor
Posit Science Corporation
Collaborators
University of California, San Francisco, Case Western Reserve University
Responsible party
Sponsor
First posted
Jul 23, 2007
Start date
Jun 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Feb 5, 2016

Study contacts

Henry Mahncke, PhD
principal investigator · Posit Science Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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