The NeuroFab Study: Two year follow-up of Cognitive and Psychological functioning in patients with Fabry Disease.

Completed

Conditions: alpha-galactosidase A deficiency
Anderson-Fabry disease
Fabry Disease
10027424
10042258
10009841

Registration Number: NL-OMON43300

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Fabry patients:
* Signed informed consent
* Agreeing to be informed about medically relevant personal test-results by a physician
* Definite diagnosis of FD according to previously developed diagnostic criteria (see protocol: appendix A, Table 1. for diagnostic criteria).

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in this study:
Fabry patients:
* Unwillingness to participate
* Uncertain FD diagnosis (not fulfilling the criteria mentioned in protocol: appendix A, Table 1)
* Unable to execute approximately two hours of neuropsychological tests
* Medical conditions which make participation in the study not feasible (e.g. other diseases than FD affecting the brain), decided by a medical doctor during screening
* Clinically relevant comorbidities, not attributable to FD, presumably influencing neuropsychological test results
* Severe hearing loss and/or vision loss resulting in inability to complete neuropsychological tests and questionnaires

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective:<br /><br>* Cognitive functioning and prevalence of cognitive and psychological<br /><br>impairment in Fabry patients assessed with a neuropsychological test battery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>* Changes in cognitive and psychological functioning and prevalence of<br /><br>cognitive impairment in Fabry patients assessed with a neuropsychological test<br /><br>battery during two years follow-up<br /><br>* Prevalence of depression assessed with The Center for Epidemiologic Studies<br /><br>Depression Scale Revised<br /><br>* Sleep quality and sleep habits assessed with the Pittsburgh Sleep Quality<br /><br>Index<br /><br>* Physical activity assessed with the International Physical Activity<br /><br>Questionnaire last seven days<br /><br>* Coping strategies assessed with the Utrecht Coping List</p><br>