Clinical trial · Interventional
Synaptic Plasticity and Cognitive Function in RASopathies
Improvement of Synaptic Plasticity and Cognitive Function in RAS Pathway Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has been terminated prematurely due to recruitment difficulties. Current status: recruitment stopped and cleaning of the database is ongoing.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Impaired Cognition | — | UNRESOLVED | — |
| Impaired Synaptic Plasticity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lamotrigine | Drug | — | UNRESOLVED |
| Lovastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Exp. I: Noonan Syndrome - Lovastatin
- description
- 200 mg Lovastatin daily for four days / Lovastatin-placebo (cross-over) prior to transcranial magnetic stimulation and test of attentional performance
- interventionNames
- Drug: Lovastatin
- type
- EXPERIMENTAL
- label
- Exp. II: Noonan Syndrome - Lamotrigine
- description
- 300 mg Lamotrigine single dose / Lamotrigine-placebo prior to transcranial magnetic stimulation and test of attentional performance
- interventionNames
- Drug: Lamotrigine
- type
- EXPERIMENTAL
- label
- Exp. III: Neurofibromatosis Type 1 - Lamotrigine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Group 1: NS, Group 2: NF1 (both genetically assured) 2. Age ≥16 years 3. 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. 4. Signed informed consent if ≥ 16 years and legal guardian. 5. 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. 6. Signed informed consent if ≥ 18 years. 7. 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: 1. Epilepsy 2. Medication with known CNS effects 3. Severe mental retardation 4. Side effects during previous medication with and contraindications for LTG and/or LOV and/or TMS 5. Psychiatric diseases 6. Previous history of allergic reactions with LTG and LOV medications 7. Potentially unreliable patients 8. Patients who are not suitable for the study in the opinion of the investigator 9. Pregnancy (incl. positive urine pregnancy test) 10. Persons who are incapable of giving consent or do not understand the aim or rationale of the study.
References
Publications (2)
- BACKGROUNDMainberger 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. PMID 24088225
- DERIVEDJung 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. PMID 37280688