The effect of long-term Simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial.

Completed

• Conditions: eurofibromatosis 1; Neurofibromatose type 1; NF1

• Registration Number: NL-OMON25915
• Lead Sponsor: Erasmus MC – Sophia’s Children Hospital

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. Age 8 to 16 years;

2. NF1 diagnosis with genetic confirmation;

Exclusion Criteria

1. Segmental NF1;

2. Pathology of the CNS (other than asymptomatic gliomas);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cognitive Function: WISC III-R;<br /><br>2. Behavioral Problems on the Child Behavioral Checklist (CBCL, parents): internalizing behavioral problems, attention problems.

Secondary Outcome Measures

Name	Time	Method
1. School performance: Teacher ratings form the Teacher Report Form;<br /><br>2. Quality of Life: CHQPF50 Child Quality of Life Questionnaire;<br /><br>3. Behavior (other): internalizing problems rated by children on the Youth Self Report;<br /><br>4. Cognitive Function (other): Non-verbal Long term Memory by the Rey Complex Figure test – delayed recall;<br /><br>5. Attention (other): Stroop color word test;<br /><br>6. Fine motor coordination: Grooved Pegboard test.