Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy — LiBRA  

Cognitive Impairment Clinical Trial

Official title: Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Status Recruiting

Clinical Trial Summary

Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol/l) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.

Primary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.

Clinical Trial Description

Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options and quality of life. There is no current interventional drug treatment to prevent this intellectual impairment after brain tumor treatment.

Primary objective:

To assess the efficacy of lithium treatment (up to 7 years) after brain radiotherapy (both whole brain and focal) for central nervous system malignancy in preventing late-appearing cognitive processing speed impairment in children aged 5 or older.

Secondary objectives:

• To assess the efficacy of lithium treatment through evaluation of other neuropsychological/quality of life test scores.

• To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using Magnetic Resonance Imaging (MRI) of the brain.

Exploratory objectives:

To explore the feasibility, safety and tolerability of lithium treatment in this patient group, using side effect forms/adverse events (AE) reporting and laboratory measures. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Late Effect of Radiation
• Memory Impairment
• Radiotherapy Side Effect
• Radiotherapy; Complications

• NCT number: NCT06051240
• Study type: Interventional
• Source: Region Stockholm
• Contact: Klas Blomgren, MD, Professor
• Phone: 0046703233353
• Email: klas.blomgren@regionstockholm.se
• Status: Recruiting
• Phase: Phase 2
• Start date: February 16, 2024
• Completion date: August 31, 2033