Clinical trial · Interventional
From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1
Linking Inhibition From Molecular to Systems and Cognitive Levels: a Preclinical and Clinical Approach in Autism Spectrum Disorders and Neurofibromatosis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate synaptic physiology and behavioral inhibition in patients with NF1 and ASD and to answer whether inhibitory deficits at these levels are modulated by lovastatin. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autism Spectrum Disorder | — | UNRESOLVED | — |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lovastatin 60 MG | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- NF1 - experimental
- interventionNames
- Drug: Lovastatin 60 MG
- type
- PLACEBO_COMPARATOR
- label
- NF1 - control
- interventionNames
- Drug: Placebos
- type
- EXPERIMENTAL
- label
- ASD - experimental
- interventionNames
- Drug: Lovastatin 60 MG
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Positive diagnostic results for ASD in: 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: * Global Intelligence Quotient \< 80 * 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
References
Publications (3)
- BACKGROUNDPizzarelli 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. PMID 21766041
- BACKGROUNDViolante 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. PMID 23404336
- DERIVEDBernardino 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. PMID 35970940