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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
Study open to all English speakers regardless of race, gender, minority, or socioeconomic status
Female participants must be post-menarche for NF patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 speak English and am open to participating regardless of my background.
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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 male with NF and have started puberty.
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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 am between 8 and 17 years old.
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I can swallow pills.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,143,211 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,100 Total Patients Enrolled
Laurie Cutting, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Reading Tutoring Intervention Clinical Trial Eligibility Overview. Trial Name: NCT02964884 — Phase 2
Neurofibromatosis Research Study Groups: RD: Other Academic (sham) tutoring, NF1: Lovastatin + reading tutoring, NF1: Placebo + reading tutoring, RD: Reading tutoring
Neurofibromatosis Clinical Trial 2023: Reading Tutoring Intervention Highlights & Side Effects. Trial Name: NCT02964884 — Phase 2
Reading Tutoring Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT02964884 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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 clinicaltrials.gov was on June 20th 2022."

Answered by AI

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."

Answered by AI
~1 spots leftby May 2024