NF1: Lovastatin + reading tutoring for Neurofibromatosis

Vanderbilt University, Nashville, TN
Neurofibromatosis+3 More ConditionsLovastatin - Drug
8 - 20
All Sexes

Study Summary

This trial will study whether the combination of a medication and reading tutoring can help improve learning disabilities in children with Neurofibromatosis Type 1.

Eligible Conditions
  • Neurofibromatosis Type 1
  • Dyslexia
  • Learning Disabilities

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
Clinical Evaluation of Language Fundamentals-Fifth Edition
Comprehensive Test of Phonological Processing-2
Delis Kaplan Executive Function System
Experimental Word and Pseudoword Lists
Test of Silent Contextual Reading Fluency-2
Test of Word Reading Efficiency-2
Visuospatial Learning and Memory, Judgment of Line Orientation
Woodcock Johnson Tests of Achievement IV
Woodcock Reading Mastery Test-III

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4 Treatment Groups

NF1: Lovastatin + reading tutoring
1 of 4
NF1: Placebo + reading tutoring
1 of 4
RD: Other Academic (sham) tutoring
1 of 4
RD: Reading tutoring
1 of 4

Active Control

Non-Treatment Group

120 Total Participants · 4 Treatment Groups

Primary Treatment: NF1: Lovastatin + reading tutoring · Has Placebo Group · Phase 2

NF1: Placebo + reading tutoringPlaceboComparator Group · 2 Interventions: Placebo Oral Tablet, reading tutoring intervention · Intervention Types: Drug, Behavioral
RD: Other Academic (sham) tutoring
ShamComparator Group · 1 Intervention: Other Academic "sham" tutoring · Intervention Types: Behavioral
RD: Reading tutoring
PlaceboComparator Group · 1 Intervention: reading tutoring intervention · Intervention Types: Behavioral
NF1: Lovastatin + reading tutoringActiveComparator Group · 2 Interventions: Lovastatin, reading tutoring intervention · Intervention Types: Drug, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
687 Previous Clinical Trials
6,132,782 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,863 Previous Clinical Trials
2,167,117 Total Patients Enrolled
Laurie Cutting, PhDPrincipal InvestigatorVanderbilt University Medical Center
Sheryl L. Rimrodt-Frierson, MDStudy DirectorVanderbilt University Medical Center

Eligibility Criteria

Age 8 - 20 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study is only for children between 8 and 17 years old.
You speak English as your first language.

Frequently Asked Questions

If I meet the requirements, can I sign up for this clinical trial?

"This study is recruiting 120 individuals aged 8-20 who have been diagnosed with learning disorders. To be eligible, participants must also meet the following criteria: - Be able to swallow a capsule (this will be confirmed via a swallowability test)- Have English skills that are sufficient for school- For parents: Has your child ever been diagnosed with a reading disability? Did your child have trouble learning how to "sound out" words? Have you (parent) ever been concerned about your child's reading ability? Did the school or teacher ever express any concerns about your child's reading ability? Child 7 years" - Anonymous Online Contributor

Unverified Answer

Does the combined treatment of lovastatin and reading tutoring present any health risks for patients?

"So far, the evidence suggests that NF1: Lovastatin + reading tutoring is safe but not necessarily effective. Our team gave it a safety score of 2." - Anonymous Online Contributor

Unverified Answer

What pediatric patients does the NF1: Lovastatin + reading tutoring intervention typically target?

"Coronary heart disease (CHD) is often treated with a combination of lovastatin and reading tutoring. This treatment approach can also help improve other conditions like dyslipidemias, coronary artery atherosclerosis, and apolipoprotein levels." - Anonymous Online Contributor

Unverified Answer

Are there many case studies of NF1 patients being helped by Lovastatin + reading tutoring?

"There are three ongoing clinical trials testing the efficacy of lovastatin + reading tutoring for NF1 patients. Of these, none have progressed to Phase 3 yet. The majority of these trials are being conducted in Beijing, but there are also three taking place in other locations." - Anonymous Online Contributor

Unverified Answer

Are patients able to enroll in this trial at this time?

"This clinical trial, which was first posted on November 1st 2016, is currently recruiting candidates. The last update to the listing on was on June 20th 2022." - Anonymous Online Contributor

Unverified Answer

Does this research allow octogenarians to participate?

"To participate in this trial, applicants must be between 8 and 20 years old. Out of the 106 total studies, 66 are for patients under 18 and 40 are for patients over 65." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.