NCT00879502

Brief Summary

This study will examine whether individuals with the fragile X genetic premutation are likely to have emotional, social, and memory deficits and how the brain may be involved in these deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

5.7 years

First QC Date

April 9, 2009

Last Update Submit

May 25, 2017

Conditions

Fragile X Premutation

Keywords

Fragile X PremutationFMR1PremutationFragile XBrain Function

Outcome Measures

Primary Outcomes (1)

  • Amygdala and hippocampus volume and function

    Age at time of visit

Study Arms (3)

1

Men with the fragile X premutation

2

Healthy men

3

Brothers of men with the fragile X premutation

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Members of the general population, those with the fragile X premutation, and the brothers of those with the fragile X premutation

You may qualify if:

  • Possesses FMR1 premutation or is part of the general population control group
  • Normal or corrected vision
  • Speaks English

You may not qualify if:

  • Presence of contraindication for brain MRI, such as having metal in the body
  • Presence of a major medical condition, such as kidney, heart, or liver disease
  • Presence of a neurological disorder
  • Current alcohol or drug abuse or dependence
  • History of head trauma
  • History of brain infection
  • Medication affecting cerebral blood flow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.I.N.D. Institute, U.C. Davis

Sacramento, California, 95817, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood samples

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Study Start

June 1, 2007

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)