Blood Neurotrophic Factors in Adults

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Case Western Reserve University
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT00505349
First received: July 19, 2007
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Healthy
Behavioral: Computer-based cognitive training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Blood Neurotrophic Factors in Adults

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505349

Locations
United States, California
Posit Science Corporation
San Francisco, California, United States, 94104
Sponsors and Collaborators
Posit Science Corporation
University of California, San Francisco
Case Western Reserve University
Investigators
Principal Investigator: Henry Mahncke, PhD Posit Science Corporation
  More Information

No publications provided

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT00505349     History of Changes
Other Study ID Numbers: OUT-117-2005
Study First Received: July 19, 2007
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Posit Science Corporation:
neurotrophic factors
cognitive status
young adults
mature adults
cognitive training

ClinicalTrials.gov processed this record on August 20, 2014