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Medication + Reading Tutoring for Learning Disabilities in Neurofibromatosis Type 1

Phase 2

Recruiting

Led By Laurie Cutting, PhD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants must be post-menarche for NF patients

Documented NF-1 for NF patients

Must not have

Stroke caused by Bleeding in the Brain, Loss of Memory

Children with conditions contraindicated to Lovastatin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

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.

Who is the study for?

This trial is for English-speaking individuals aged 8-20 with Neurofibromatosis Type 1 (NF1) and reading disabilities. They must be able to swallow capsules, have documented NF-1, and females should be post-menarche. Exclusions include living outside the US, pregnancy, liver or severe kidney issues, recent surgery or injury, excessive alcohol use, certain medications or conditions contraindicating Lovastatin.

What is being tested?

The study tests if a medication called Lovastatin combined with specialized reading tutoring can help improve learning disabilities in those with NF1. Participants will either receive Lovastatin or a placebo tablet alongside real or 'sham' academic tutoring to compare effects on their reading abilities.

What are the potential side effects?

Lovastatin may cause side effects like muscle pain/tenderness potentially leading to kidney problems, liver function changes, digestive issues such as stomach upset and constipation; it could also affect blood sugar levels and result in memory loss or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a female and have started menstruating.

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I have a confirmed diagnosis of Neurofibromatosis type 1.

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I am a native English speaker.

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I am between 8 and 20 years old.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke due to brain bleeding and have memory loss.

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My child cannot take Lovastatin due to their condition.

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I have muscle damage from an autoimmune condition.

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I have severe kidney problems.

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I experience muscle pain and have high levels of creatinine kinase.

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My child is on medication for mental health issues.

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I have a known neurological condition such as epilepsy or cerebral palsy.

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My IQ is below 70.

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I have Metabolic Syndrome X and high blood sugar.

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I have epilepsy that is not well-controlled.

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I have very low blood pressure.

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I have liver issues or abnormal liver test results.

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My child is 7 years old or younger.

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I have serious muscle damage that could cause kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Evaluation of Language Fundamentals-Fifth Edition

Comprehensive Test of Phonological Processing-2

Delis Kaplan Executive Function System

+7 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: NF1: Lovastatin + reading tutoringActive Control2 Interventions

Participants (NF-1 patients) will receive 20mg of Lovastatin per day for the first two weeks, the dose will be escalated 40 mg for the remaining 11 weeks. And one week of intensive, one-on-one reading tutoring intervention

Group II: RD: Other Academic (sham) tutoringPlacebo Group1 Intervention

Participants (RD-only participants) will receive one week of intensive, one-on-one tutoring intervention with an academic focus other than reading. These participants will have the opportunity to receive reading tutoring upon finishing study participation.

Group III: NF1: Placebo + reading tutoringPlacebo Group2 Interventions

Participants (NF-1 patients) will receive placebo daily And one week of intensive, one-on-one reading tutoring intervention

Group IV: RD: Reading tutoringPlacebo Group1 Intervention

Participants (RD-only participants) will receive one week of intensive, one-on-one reading tutoring intervention

0 / 19Eligibility criteria met