From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1
NCT ID: NCT03826940
Last Updated: 2021-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2019-02-19
2020-08-31
Brief Summary
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Structure: (1) Visit 1: Baseline assessment- participant's characterization, baseline outcome measures and additional evaluations, (2) 3 consecutive days of physiologically probing drug/placebo intake, (3) Visit 2: Outcome measures and additional evaluations in the day after the last drug/placebo intake, (4) Washout period of 4 to 6 weeks, (5) 3 consecutive days of drug/placebo intake, (6) Visit 3: Outcome measures and additional evaluations in the day after the last placebo/drug intake.
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Detailed Description
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The intervention comprehends three sessions: the first two visits will occur in the same week and the third visit will take place 4 to 6 weeks later. In the first visit (baseline assessment), participants will perform neuropsychological, EEG, MRS and TMS assessment. In the other two visits participants will repeat EEG, MRS and TMS assessments to study possible post- intervention effects. Participants will intake 60mg of Lovastatin or Placebo during three consecutive days before the second and the third visits.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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NF1 - experimental
Lovastatin 60 MG
60 MG Lovastatin per day for 3 consecutive days
NF1 - control
Placebos
60 MG Placebo per day for 3 consecutive days
ASD - experimental
Lovastatin 60 MG
60 MG Lovastatin per day for 3 consecutive days
ASD - control
Placebos
60 MG Placebo per day for 3 consecutive days
Interventions
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Lovastatin 60 MG
60 MG Lovastatin per day for 3 consecutive days
Placebos
60 MG Placebo per day for 3 consecutive days
Eligibility Criteria
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Inclusion Criteria
The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
* Positive diagnostic results for NF1:
Clinical diagnosis based on the well-established clinical criteria
Exclusion Criteria
* Associated medical condition such as epilepsy, neurologic conditions, genetic syndromes, or other usual comorbidity in ASD and NF1 populations
* Medication capable of interfering with the intervention and/or study results
* Pregnancy
* Drug use and/or alcohol abuse
* Contra-indications to MR and TMS
16 Years
65 Years
ALL
No
Sponsors
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University of Coimbra
OTHER
Responsible Party
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Miguel Castelo-Branco
Research Director of CIBIT-ICNAS
Principal Investigators
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Miguel S Castelo-Branco, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ICNAS - Institute of Nuclear Sciences Applied to Health
Locations
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ICNAS
Coimbra, , Portugal
Countries
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References
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Pizzarelli R, Cherubini E. Alterations of GABAergic signaling in autism spectrum disorders. Neural Plast. 2011;2011:297153. doi: 10.1155/2011/297153. Epub 2011 Jun 23.
Violante IR, Ribeiro MJ, Edden RA, Guimaraes P, Bernardino I, Rebola J, Cunha G, Silva E, Castelo-Branco M. GABA deficit in the visual cortex of patients with neurofibromatosis type 1: genotype-phenotype correlations and functional impact. Brain. 2013 Mar;136(Pt 3):918-25. doi: 10.1093/brain/aws368. Epub 2013 Feb 11.
Bernardino I, Dionisio A, Castelo-Branco M. Cortical inhibition in neurofibromatosis type 1 is modulated by lovastatin, as demonstrated by a randomized, triple-blind, placebo-controlled clinical trial. Sci Rep. 2022 Aug 15;12(1):13814. doi: 10.1038/s41598-022-17873-x.
Other Identifiers
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FLAD Life Science 2020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CRU2C-ICNAS-001
Identifier Type: -
Identifier Source: org_study_id
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