Blood Neurotrophic Factors in Adults

Healthy Clinical Trial

Official title:

Blood Neurotrophic Factors in Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00505349
• Other study ID #: OUT-117-2005
• Status: Withdrawn
• Phase: N/A
• First received: July 19, 2007
• Last updated: February 4, 2016
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: February 2016
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.)

Locations

Country	Name	City	State
United States	Posit Science Corporation	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Posit Science Corporation	Case Western Reserve University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 14 weeks post-enrollment	Yes
Secondary	To obtain information on the levels of growth factors in health adults		Required blood draws at three study intervals	No