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Cited by 58Genetics and Neurodevelopmental DisordersAutism Spectrum Disorder ResearchLanguage Development and Disorders

Controlled trial of lovastatin combined with an open-label treatment of a parent-implemented language intervention in youth with fragile X syndrome

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Thurman, Angela John, Potter, Laura A., Kim, Kyoungmi, Tassone, Flora, Banasik, Amy, Potter, Sarah Nelson, Bullard, Lauren, Nguyen, Vivian +3 more·2020·Journal of Neurodevelopmental Disorders
DOI 10.1186/s11689-020-09315-4PMC PMC7175541
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Abstract

Background: The purpose of this study was to conduct a 20-week controlled trial of lovastatin (10 to 40 mg/day) in youth with fragile X syndrome (FXS) ages 10 to 17 years, combined with an open-label treatment of a parent-implemented language intervention (PILI), delivered via distance video teleconferencing to both treatment groups, lovastatin and placebo. Method: A randomized, double-blind trial was conducted at one site in the Sacramento, California, metropolitan area. Fourteen participants were assigned to the lovastatin group; two participants terminated early from the study. Sixteen participants were assigned to the placebo group. Lovastatin or placebo was administered orally in a capsule form, starting at 10 mg and increasing weekly or as tolerated by 10 mg increments, up to a maximum dose of 40 mg daily. A PILI was delivered to both groups for 12 weeks, with 4 activities per week, through video teleconferencing by an American Speech-Language Association-certified Speech-Language Pathologist, in collaboration with a Board-Certified Behavior Analyst. Parents were taught to use a set of language facilitation strategies while interacting with their children during a shared storytelling activity. The main outcome measures included absolute change from baseline to final visit in the means for youth total number of story-related utterances, youth number of different word roots, and parent total number of story-related utterances. Results: Significant increases in all primary outcome measures were observed in both treatment groups. Significant improvements were also observed in parent reports of the severity of spoken language and social impairments in both treatment groups. In all cases, the amount of change observed did not differ across the two treatment groups. Although gains in parental use of the PILI-targeted intervention strategies were observed in both treatment groups, parental use of the PILI strategies was correlated with youth gains in the placebo group and not in the lovastatin group. Conclusion: Participants in both groups demonstrated significant changes in the primary outcome measures. The magnitude of change observed across the two groups was comparable, providing additional support for the efficacy of the use of PILI in youth with FXS. Trial registration: US National Institutes of Health ( ClinicalTrials.gov ), NCT02642653 . Registered 12/30/2015.

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  • Lovastatin did not enhance the treatment response of parent-implemented language intervention in a randomized, double-blind trial.

    “However, lovastatin did not enhance the treatment response of parent-implemented language intervention in a randomized, double-blind trial18, and it remained unclear whether lovastatin has less effect on speech-related mechanisms than mechanisms underlying other symptoms such as hyperactivity and stereotypy in FXS.”

    From An iPSC-derived astrocyte model of fragile X syndrome exhibits dysregulated cholesterol homeostasis (2023) · cites this paper as [18]

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Authors
Thurman, A. J., Potter, L. A., Kim, K., Tassone, F., Banasik, A., Potter, S. N., Bullard, L., Nguyen, V., McDuffie, A., Hagerman, R., & Abbeduto, L.
Affiliations
  • University of California Davis Medical Center (US)
  • UC Davis Health (US)
Corresponding author
Thurman, Angela John
ORCID
Venue
Journal of Neurodevelopmental Disorders
Publisher
Springer Science and Business Media LLC
Published
2020-04-22
Volume
12
Issue
1
Pages
12-12
ISSN
  • 1866-1947 (ISSN-L)
  • 1866-1955
DOI
10.1186/s11689-020-09315-4
PMC
PMC7175541
OpenAlex
W3016332336
Cited by
58
References
9
Citations by year
2026: 4 · 2025: 5 · 2024: 8 · 2023: 12 · 2022: 13 · 2021: 9 · 2020: 7
FWCI
6.00
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Neurodevelopmental Disorders (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54HD079125)
  • National Center for Advancing Translational Sciences (UL1 TR000002)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
  • Social Sciences › Psychology › Developmental and Educational Psychology › Language Development and Disorders
Keywords
fragile X syndrome, lovastatin, videoconferencing, language intervention, language development, social dysfunction, statins
MeSH terms
Adolescent, California, Child, Communication, Double-Blind Method, Female, Fragile X Syndrome, Humans, Language, Language Therapy, Lovastatin, Male, Mothers, Telecommunications, Outcome Assessment, Health Care

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