Blood Neurotrophic Factors in Adults

February 4, 2016 updated by: Posit Science Corporation
The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94104
        • Posit Science Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 14 weeks post-enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
To obtain information on the levels of growth factors in health adults
Time Frame: Required blood draws at three study intervals
Required blood draws at three study intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Posit Science Corporation

Collaborators

University of California, San Francisco
Case Western Reserve University

Investigators

  • Principal Investigator: Henry Mahncke, PhD, Posit Science Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OUT-117-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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