Improvement of Synaptic Plasticity and Cognitive Function in RAS Pathway Disorders

Who is this study for? Patients with RAS pathway disorders
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: No
View:

• Group 1: NS, Group 2: NF1 (both genetically assured)

• Age >18 years

• Signed informed consent.

• Persons 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.

• 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.

Locations
Other Locations
Germany
Technical University Munich
Recruiting
Munich
Contact Information
Primary
Volker Mall, Prof.
volker.mall@kbo.de
+49 (0)89 71009-233
Backup
Nikolai Jung, Dr.
nikolai.jung@tum.de
+49 (0)89 71009-236
Time Frame
Start Date: March 22, 2019
Estimated Completion Date: January 2023
Participants
Target number of participants: 14
Treatments
Experimental: Exp. I: Noonan Syndrome - Lovastatin
200 mg Lovastatin daily for four days / Lovastatin-placebo (cross-over) prior to transcranial magnetic stimulation and test of attentional performance
Experimental: Exp. II: Noonan Syndrome - Lamotrigine
300 mg Lamotrigine single dose / Lamotrigine-placebo prior to transcranial magnetic stimulation and test of attentional performance
Experimental: Exp. III: Neurofibromatosis Type 1 - Lamotrigine
300 mg Lamotrigine single dose / Lamotrigine-placebo prior to transcranial magnetic stimulation and test of attentional performance
Related Therapeutic Areas
Sponsors
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov

Similar Clinical Trials