From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT03826940
• Date of registration: 23/01/2019
• Prospective Registration: Yes
• Primary sponsor: University of Coimbra
• Public title: From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1 ASD/NF1inhib
• Scientific title: Linking Inhibition From Molecular to Systems and Cognitive Levels: a Preclinical and Clinical Approach in Autism Spectrum Disorders and Neurofibromatosis.
• Date of first enrolment: February 19, 2019
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03826940
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Portugal

Contacts

• Name: Miguel S Castelo-Branco, MD, PhD
• Affiliation: ICNAS - Institute of Nuclear Sciences Applied to Health

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorder

Neurofibromatosis 1

Intervention(s)

Drug: Placebos

Drug: Lovastatin 60 MG

Primary Outcome(s)

Neurochemical response changes to GABAergic stimulation [Time Frame: Through study completion, an average of 1 year]

Secondary Outcome(s)

Event-related potentials changes under sensory stimulation [Time Frame: Through study completion, an average of 1 year]

Motor evoked potentials changes under motor cortical stimulation [Time Frame: Through study completion, an average of 1 year]

Brain oscillations changes under sensory stimulation [Time Frame: Through study completion, an average of 1 year]

Cortical excitability changes under motor cortical stimulation [Time Frame: Through study completion, an average of 1 year]

Secondary ID(s)

CRU2C-ICNAS-001

FLAD Life Science 2020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors