Clinical trial NCT00505349: Blood Neurotrophic Factors in Adults
Official title: Blood Neurotrophic Factors in Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: neurotrophic factors
cognitive status
young adults
mature adults
cognitive training
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
name: Case Western Reserve University
First posted: 2007-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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 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

Primary outcomes:
measure: 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.
timeFrame: Up to 14 weeks post-enrollment
Secondary outcomes:
measure: To obtain information on the levels of growth factors in health adults
timeFrame: Required blood draws at three study intervals
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Henry Mahncke, PhD
role: PRINCIPAL_INVESTIGATOR
References: