NCT00505349

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

July 19, 2007

Last Update Submit

February 4, 2016

Conditions

Healthy

Keywords

neurotrophic factorscognitive statusyoung adultsmature adultscognitive training

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To obtain information on the levels of growth factors in health adults

    Required blood draws at three study intervals

Study Arms (2)

No Intervention Arm

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.

Cognitive Training

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. Participants randomized to this arm will receive SAAGE-based computerized cognitive training.

Behavioral: Computer-based cognitive training

Interventions

Computer-based cognitive trainingBEHAVIORAL

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.)

Cognitive Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Reported or observed difficulties with a participant's dominant hand
  • Current diagnosis of a major psychological disorder or a psychiatric hospitalization
  • Current substance abuse, including alcoholism
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94104, United States

Location

Study Officials

  • Henry Mahncke, PhD

    Posit Science Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 23, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(1)