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Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

NCT06051240 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lithium

Lithium sulphate, 42 mg (6 mmol lithium)

DRUG

Placebo

White round tablet, 10 mm. Identical to experimental drug (lithium)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Region Stockholm

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2030-08-31
Completion
2033-08-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051240 on ClinicalTrials.gov