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ACTIVE NOT RECRUITING
NCT02964884
PHASE2

Interventions for Reading Disabilities in NF1

Sponsor: Vanderbilt University

View on ClinicalTrials.gov

Summary

Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring.

Official title: Neurobiology and Treatment of Reading Disability in NF1

Key Details

Gender

All

Age Range

8 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2016-11

Completion Date

2027-01

Last Updated

2025-06-24

Healthy Volunteers

Yes

Interventions

DRUG

Lovastatin

Those in the Lovastatin group will receive 20mg of Lovastatin per day for the first two weeks and 40mg of Lovastatin per day starting at week 3 through week 11.

BEHAVIORAL

reading tutoring intervention

After the initial 12 weeks of Lovastatin or placebo, children will return for one week of intensive, one-on-one tutoring intervention (either reading or sham; Visit 2)

DRUG

Placebo Oral Tablet

Those in the placebo group will receive a tablet daily

BEHAVIORAL

Other Academic "sham" tutoring

No reading (sham) tutoring. Children will receive intensive tutoring on a subject other than reading.

Locations (1)

Vanderbilt University

Nashville, Tennessee, United States