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LiBRA – Lithium treatment to prevent cognitive impairment after brain radiotherapy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504071-24-00
Acronym
LiBRA
Enrollment
114
Registered
2023-05-02
Start date
2023-11-07
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumor

Brief summary

Change in Processing Speed Index (PSI) test score (sub-test of WPPSI/WISC/WAIS) 2 years after the start of study treatment compared to baseline, before study treatment.

Detailed description

Changes in the following neuropsychological/other test scores: • Complete set of WPPSI-IV/WISC-V/WAIS-IV sub-tests and their associated indices: o Processing Speed Index (PSI) o Verbal Comprehension Index (VCI) o Visual Spatial Index (VSI) o Fluid Reasoning Index (FRI) o Working Memory Index (WMI), Changes in Grooved Pegboard (motor speed), Changes in Beery/Buktenica VMI (visual-motor integration), Changes in Conner´s CPT III (sustained attention), Changes in D-KEFS TMT, D-KEFS CWT, D-KEFS Verbal fluency (executive functions) o If age <8 years: Nepsy II: Inhibition, Verbal fluency, Changes in Nepsy Word list (memory), Changes in Pediatric Quality of Life (PedsQL) Generic Core Scale Standard, Multidimensional Fatigue Scale., Changes in UCLA Loneliness Rating Scale 3 (ULS-3), Changes in Strengths and Difficulties Questionnaire (SDQ), Changes in Behavior Rating Inventory of Executive Function (BRIEF), Changes in the following neuropsychological/other test scores: o Processing Speed Index (PSI) o Working Memory Index (WMI), Evaluation of volumetric measures (hippocampal, total gray matter and total white matter volume) and diffusion tensor imaging (DTI) indices (FA, MD, RD, AD) on brain MRI at 6 months, 1 year, 2 years, 5 years and 10 years after start of study treatment, compared to baseline.

Interventions

DRUGLithionit 42 mg (6 mmol) depottablett
DRUGPLACEBO MATCHING 42MG LITHIONIT
DRUG10MM
DRUGWHITE
DRUGROUND TABLETS

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in Processing Speed Index (PSI) test score (sub-test of WPPSI/WISC/WAIS) 2 years after the start of study treatment compared to baseline, before study treatment.

Secondary

MeasureTime frame
Changes in the following neuropsychological/other test scores: • Complete set of WPPSI-IV/WISC-V/WAIS-IV sub-tests and their associated indices: o Processing Speed Index (PSI) o Verbal Comprehension Index (VCI) o Visual Spatial Index (VSI) o Fluid Reasoning Index (FRI) o Working Memory Index (WMI), Changes in Grooved Pegboard (motor speed), Changes in Beery/Buktenica VMI (visual-motor integration), Changes in Conner´s CPT III (sustained attention), Changes in D-KEFS TMT, D-KEFS CWT, D-KEFS Verbal fluency (executive functions) o If age <8 years: Nepsy II: Inhibition, Verbal fluency, Changes in Nepsy Word list (memory), Changes in Pediatric Quality of Life (PedsQL) Generic Core Scale Standard, Multidimensional Fatigue Scale., Changes in UCLA Loneliness Rating Scale 3 (ULS-3), Changes in Strengths and Difficulties Questionnaire (SDQ), Changes in Behavior Rating Inventory of Executive Function (BRIEF), Changes in the following neuropsychological/other test scores: o Processing Speed Inde

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026