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Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)

Phase 1
10 Years
50 Years
Open (Enrolling)
Neurofibromatosis 1

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Trial Information

Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)

Inclusion Criteria:

1. a diagnosis of NF1 by NIH criteria

2. between 10 and 50 years of age

3. no evidence of a comorbid neurological disorder (e.g., epilepsy, encephalitis)

4. not currently taking a statin medication

5. not suffering from hypercholesterolemia based on self-report, collateral information
from physician, or initial medical workup using National Cholesterol Education
Program (NCEP, JAMA 2001), guidelines accepted by the American College of Cardiology
(ACC) and the American Heart Association (AHA)

6. does not have any of the aforementioned conditions that contraindicates use of statin
medications (such as pregnancy, lactation, liver disease, or use of other medication
not recommended for use in conjunction with lovastatin). A negative pregnancy test
will be required if the patient is a female in reproductive years.

7. not mentally retardation (i.e., IQ greater than 70)

8. no evidence of significant and habitual alcohol or drug abuse or dependence

9. sufficient acculturation and fluency in the English language to avoid invalidating
research measures of thought, language, and speech disorder, and verbal abilities.

10. lives in Southern California area (or can arrange ~5 visits to Los Angeles over 14

Exclusion Criteria:

1. comorbid neurological conditions

2. significant drug or alcohol abuse

3. non-fluency in English

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Non-verbal learning

Outcome Time Frame:

14 weeks

Safety Issue:


Principal Investigator

Carrie E Bearden, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Neurofibromatosis 1
  • Neurofibromatosis Type 1
  • NF1
  • Lovastatin
  • statin
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica



Semel Institute for Neuroscience and Human Behavior Los Angeles, California  90095