NCT00713570

Brief Summary

Genetic research has provided the most exciting breakthroughs in neuroscience and cognitive science. Partially genetically determined cognitive impairments have been described in people with COMT, 5HT6, BDNF (Swillen et al., 2000; Moss et al., 1999, Henry et al., 2002, Bilder et al., 2002)and biological systemic pathway candidate genes. Selective inhibitors of COMT proved to improve cognitive function in animals and in patients with Parkinson's disease (Carlsson, et al, 2000). Recent studies suggested that variation in COMT activity might have neurobiological effects specific to the prefrontal cortex; the COMT (Val) allele with high activity impairs tasks of prefrontal cognition in people with schizophrenia (Egan et al., 2001) and higher loading of the COMT (Met) allele is associated with better cognitive performance on attention and processing speed in people with chronic schizophrenia (Bilder et al., 2002). Moreover, prefrontal dopamine levels are increased in COMT knockout mouse model (Gogos et al., 1998). This suggests that in people who have heterozygosis on COMT, dopamine levels could be abnormal. Thus, variation in COMT expression could also affect performance on prefrontal cognitive tasks. In the previous study, we found the neuropsychological profile in students with COMT (Met) allele is better in object perception, problem solving and planning, and abstract and social thinking (Henry et al., 2002). 5-HT6 inhibitor has been reported to raise extracellular acetylcholine levels in the cortex and hippocampus (Dawson et al., 2001 and Riemer et al., 2003). Acetylcholine release in hippocampal and cortical regions is known to be important for memory acquisition and retention, and several groups have demonstrated that 5-HT6 blockade overcomes scopolamine-induced amnesia. We hypothesize that variations in COMT and 5-HT6 are associated with genotype that will cause a poor/better performance in cognitive tasks. With the aim to establish the possible correlation between candidate genes (COMT, 5HT6,BDNF and biological systemic pathway candidate genes. etc) and cognitive ability, which will provide us an understanding on factors and its extent that affect students' thinking, and then develop appropriate teaching models or strategies for assisting students in learning. It seems timely, therefore, to consider how we might implement our increased understanding of brain development and brain function to explore educational questions.

Trial Health

55
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Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

5.9 years

First QC Date

July 9, 2008

Last Update Submit

December 10, 2010

Conditions

Keywords

intellectual functioningmemory,visual-spatial and perceptual functionscognitive abilitiesCOMTBDNFneuron biological systemic pathway candidate genesChineseTaiwanHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • observational studies, related to core objectives of the study and learning.

    at least five years follow

Study Arms (1)

A,1,II

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Taiwan genernal population

You may qualify if:

  • Healthy volunteers with inform concern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Yi Hu

Taipei, Taiwan

RECRUITING

Study Officials

  • Chung Yi Hu, PhD

    Department of Clinical Laboratory Sciences and Medical Biotechonology

    PRINCIPAL INVESTIGATOR
  • Chun-Yen Chang, PhD

    Professor of Department of Earth Sciences Director of Science Education Center,PI of Building the e-Learning Research Teams for Excellence National Taiwan Normal University

    PRINCIPAL INVESTIGATOR
  • Ting-Chi Yeh, MD

    Division of Pediatric Hematology-Oncology, Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Yi Hu, PhD

CONTACT

Chun-Yen Chang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

August 1, 2006

Primary Completion

July 1, 2012

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations