Interventions for Reading Disabilities in NF1 (NCT02964884)

🧪 Interventions in This Study

• Lovastatin (DRUG)
• Placebo Oral Tablet (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. This study will be open to all English speakers who meet eligibility criteria regardless of race, gender, minority or socioeconomic status. Inclusion criteria to be met are listed below:
2. Individuals ages 8-20 (all participants)
3. Documented NF-1 (NF patients only)
4. If female, participant is post-menarche (NF patients only)
5. If male, participant has reached Tanner Stage 2 (NF patients only)
6. Participant able to swallow capsule (NF patients only, may be confirmed via swallowability test, described below)
7. Participant's English is sufficient for school (all participants)
8. Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions B-D listed below: A. Has your child ever been diagnosed with a reading disability? B. Did your child have trouble learning how to "sound out" words? C. Have you (parent) ever been concerned about your child's reading ability? D. Did the school or teacher ever express any concerns about your child's reading ability? Swallowability Assessment: We may ask patients to perform a capsule swallowability assessment prior to enrollment. We will ask subjects to attempt to swallow an empty capsule, matching the same size of the Lovastatin 20mg and 40mg capsules to be used in the study, to confirm swallowability. Patients will be provided with up to 2 capsules as needed to successfully perform the swallowability assessment. If the patient is unable to swallow the capsule, enrollment in the study may deferred or declined. A child will be excluded if he/she meets any of the following criteria, which will be determined by initial telephone screening as well as review of medical/developmental history prior to and during testing:
9. Child 7 years of age or less;
10. known uncorrectable visual impairment;
11. documented hearing impairment greater than or equal to a 25 dB loss;
12. medical contraindication to MRI procedures (e.g., metal devices);

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Vanderbilt University — Nashville, Tennessee

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.