Blood Neurotrophic Factors in Adults

NCT ID: NCT00505349

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Computer-based cognitive training

Intervention Type: BEHAVIORAL

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.)

Interventions

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.)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Mahncke, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

Posit Science Corporation

San Francisco, California, United States

Countries

United States

Other Identifiers

OUT-117-2005

Identifier Type: -

Identifier Source: org_study_id