BridgeMD
New treatment option for Cognitive Impairment
Official title Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
ClinicalTrials.gov ID: NCT06051240
What this study is testing
What is Lithium?
Lithium is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cognitive impairment.
Also referred to as Lithionit, Lithium sulphate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 and older
You may be able to join if
- Age \>5 years.
- Age \<18 years at time of radiotherapy.
- Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
- Adequate contraceptive method to prevent pregnancy\ during the entire lithium treatment period and six months thereafter.
- Negative pregnancy test\ at screening, at start of study treatment, and monthly thereafter.
You likely can't join if
- Allergy/hypersensitivity to lithium or any of the excipients
- Renal failure (Cystatin C derived Glomerular Filtration Rate \< 60).
- Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
- Uncontrolled hypothyroidism.
- Pregnancy or breast feeding.
- Severe fluid or electrolyte imbalance.
See the full eligibility criteria
- Age \>5 years.
- Age \<18 years at time of radiotherapy.
- Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
- Adequate contraceptive method to prevent pregnancy\ during the entire lithium treatment period and six months thereafter.
- Negative pregnancy test\ at screening, at start of study treatment, and monthly thereafter.
- Written informed consent from patient and/or caregiver.
- Allergy/hypersensitivity to lithium or any of the excipients
- Renal failure (Cystatin C derived Glomerular Filtration Rate \< 60).
- Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
- Uncontrolled hypothyroidism.
- Pregnancy or breast feeding.
- Severe fluid or electrolyte imbalance.
- Karnofsky-Lansky score \< 60.
- Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).
- Inclusion in other study protocol precluding inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Solna, Stockholm County, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Solna, Stockholm County, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.