drugset / Trial / NCT03504501
Synaptic Plasticity and Cognitive Function in RASopathies
RandomizedCrossoverTriple-blindTreatment
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.
Timeline
- Start
- 2019-03-22
- Primary completion
- 2023-02-09
- Completion
- 2023-10-31
Publications
- Background Mainberger F, Jung NH, Zenker M, Wahllander U, Freudenberg L, Langer S, Berweck S, Winkler T, Straube A, Heinen F, Granstrom S, Mautner VF, Lidzba K, Mall V. Lovastatin improves impaired synaptic plasticity and phasic alertness in patients with neurofibromatosis type 1. BMC Neurol. 2013 Oct 2;13:131. doi: 10.1186/1471-2377-13-131.
- Jung NH, Egert-Schwender S, Schossow B, Kehl V, Wahllander U, Brich L, Janke V, Blankenstein C, Zenker M, Mall V. Improvement of synaptic plasticity and cognitive function in RASopathies-a monocentre, randomized, double-blind, parallel-group, placebo-controlled, cross-over clinical trial (SynCoRAS). Trials. 2023 Jun 6;24(1):383. doi: 10.1186/s13063-023-07392-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamotrigine | Small molecule | 300 mg | Oral |
| Subject | Lovastatin | Small molecule | 200 mg | Oral |