Blood Neurotrophic Factors in Adults - Full Text View

Sponsors and Collaborators:	Posit Science Corporation University of California, San Francisco Case Western Reserve University
Information provided by:	Posit Science Corporation
ClinicalTrials.gov Identifier:	NCT00505349

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:	Basic Science, Open Label, Uncontrolled, Parallel Assignment, Bio-availability Study
Official Title:	Blood Neurotrophic Factors in Adults

Resource links provided by NLM:

Drug Information available for: Nerve growth factor

U.S. FDA Resources

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 ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase I: Closed: 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.
Phase II: Open: 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.	Behavioral: Computer-based cognitive training The experimental cognitive training program consists of a set of six interactive training exercises in which the participant listens to recorded sounds, including simple acoustic stimuli and continuous speech. 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.)

Arms

Assigned Interventions

Phase I: Closed: 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.

Phase II: Open: 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.

Behavioral: Computer-based cognitive training

The experimental cognitive training program consists of a set of six interactive training exercises in which the participant listens to recorded sounds, including simple acoustic stimuli and continuous speech. 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: Open @ Case Western Reserve University-UHCMC

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

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

Contacts

Contact: Karen M. McWhirter	415-394-3100	karen.mcwhirter@positscience.com
Contact: Henry Mahncke, PhD	415-394-3100	henry.mahncke@positscience.com

Locations

United States, California
Posit Science Corporation	Recruiting
San Francisco, California, United States, 94104
Contact: Karen M. McWhirter 415-394-3100 karen.mcwhirter@positscience.com
Contact: Henry W. Mahncke, PhD 415-394-3100 henry.mahncke@positscience.com

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 ( Karen McWhirter, Clinical Monitor/Project Manager )
Study ID Numbers:	OUT-117-2005
Study First Received:	July 19, 2007
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00505349 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Posit Science Corporation:

neurotrophic factors
cognitive status
young adults

mature adults
neurotrophic factors
cognitive training

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 11, 2009