Synaptic Plasticity and Cognitive Function in RASopathies (NCT03504501) | Clinical Trial Compass
TerminatedPhase 2
Synaptic Plasticity and Cognitive Function in RASopathies
Stopped: The study has been terminated prematurely due to recruitment difficulties. Current status: recruitment stopped and cleaning of the database is ongoing.
Germany16 participantsStarted 2019-03-22
Plain-language summary
The project is targeting cognitive impairment, one of the main health problems of patients with RAS pathway disorders. The aim of this study is to translate findings of animal studies to humans. This has been done by the applicants successfully for Lovastatin in Nf1. This result will be transferred to patients with Noonan Syndrome. lamotrigine is most likely a more effective and promising substance improving synaptic plasticity and consecutive cognitive function. It is expected that both substances are improving synaptic plasticity as well as alertness and changes in alertness may be a precondition for improvement of cognition.
Who can participate
Age range16 Years – 65 Years
SexALL
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Inclusion criteria
✓. Group 1: NS, Group 2: NF1 (both genetically assured)
✓. Age ≥16 years
✓. The adolescent (≥16) and legal guardian who are capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
✓. Signed informed consent if ≥ 16 years and legal guardian.
✓. Persons who are ≥ 18 years old and capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
✓. Signed informed consent if ≥ 18 years.
✓. Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.
Exclusion criteria
✕. Epilepsy
✕
What they're measuring
1
Long-term potentiation (LTP)-like plasticity measured with transcranial magnetic stimulation (TMS)