Phase
Condition
Brain Tumor
Neurofibromatosis
Precancerous Condition
Treatment
reading tutoring intervention
Lovastatin
Placebo Oral Tablet
Clinical Study ID
Ages 8-20 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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:
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:
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:
Child 7 years of age or less;
known uncorrectable visual impairment;
documented hearing impairment greater than or equal to a 25 dB loss;
medical contraindication to MRI procedures (e.g., metal devices);
any psychiatric, behavioral, or developmental disorder that would preclude active participation in in-depth tutoring sessions
Pregnant at time of screening.
Known conditions which are contraindicated to Lovastatin
Hypersensitivity to the medication
Uncontrolled Epilepsy
Metabolic Syndrome X, High Blood Sugar,
Muscle Damage Due to Autoimmunity
Stroke caused by Bleeding in the Brain, Loss of Memory,
Severely Low Blood Pressure
Liver Problems including Abnormal Liver Function Tests
Severe Renal Impairment,
Serious Muscle Damage that may Lead to Kidney Failure,
Recent Operation or significant Injury
Muscle Pain or Tenderness with Increase Creatinine Kinase,
Habit of Drinking Too Much Alcohol
Pregnant or lactating. - Lovastatin is contraindicated during pregnancy and in nursing mothers because it decreases synthesis of cholesterol and other products of the cholesterol biosynthesis pathway that are essential components for fetal development.
Children who meet criteria for ADHD, Oppositional Defiant Disorder, adjustment disorder, and/or mild depression will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for ADHD.
For pilot participants only:
Criteria for inclusion/exclusion for pilot participants is outlined below. Children who meet criteria for ADHD, Oppositional Defiant Disorder, adjustment disorder, and/or mild depression will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for ADHD.
Children ages 8-17
Participant is a native English speaker
Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions 2-4 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?
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:
Children 7 years of age or younger
previous diagnosis of Intellectual Disability;
known uncorrectable visual impairment;
documented hearing impairment greater than or equal to a 25 dB loss;
medical contraindication to MRI procedures (e.g., metal devices);
known IQ below 70;
a pervasive developmental disorder; and
any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, optic gliomas, and brain tumors (other than UBOs).
Comorbid severe psychiatric disorders will also be excluded.
Study Design
Study Description
Connect with a study center
Vanderbilt University
Nashville, Tennessee
United StatesActive - Recruiting
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