Interventions for Reading Disabilities in NF1 (NCT02964884) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Interventions for Reading Disabilities in NF1
United States120 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range
8 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Individuals ages 8-20 (all participants)
. Documented NF-1 (NF patients only)
. If female, participant is post-menarche (NF patients only)
. If male, participant has reached Tanner Stage 2 (NF patients only)
. Participant able to swallow capsule (NF patients only, may be confirmed via swallowability test, described below)
. Participant's English is sufficient for school (all participants)
. Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions B-D listed below:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Woodcock Johnson Tests of Achievement IV
Timeframe: 24 weeks
2
Woodcock Reading Mastery Test-III
Timeframe: 24 weeks
3
Test of Word Reading Efficiency-2
Timeframe: 24 weeks
4
Experimental Word and Pseudoword Lists
Timeframe: 24 weeks
5
Test of Silent Contextual Reading Fluency-2
Timeframe: 24 weeks
6
Comprehensive Test of Phonological Processing-2
Timeframe: 24 weeks
7
Delis Kaplan Executive Function System
Timeframe: 24 weeks
8
Visuospatial Learning and Memory, Morris Water Maze