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From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1

NCT03826940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-04-02

No results posted yet for this study

Summary

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

Interventions

DRUG

Lovastatin 60 MG

60 MG Lovastatin per day for 3 consecutive days

DRUG

Placebos

60 MG Placebo per day for 3 consecutive days

Sponsors & Collaborators

  • University of Coimbra

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2020-03-31
Completion
2020-08-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826940 on ClinicalTrials.gov