Ongoing Clinical Trials for Intracranial Calcification
Currently, there is one ongoing clinical trial for intracranial calcification, also known as Fahr’s Disease or Fahr’s Syndrome. This trial is investigating whether a medication called Etidronate Disodium can help slow cognitive decline in patients with abnormal calcium deposits in the brain. The study is being conducted in the Netherlands and will run for 12 months.
Clinical trial locations
- Netherlands
Study on the Effects of Etidronate on Brain Calcification in Patients with Fahr’s Disease
This clinical trial is examining the effects of Etidronate Disodium on people with Fahr’s Disease, a rare condition where calcium builds up abnormally in certain areas of the brain. These calcium deposits can affect movement, thinking abilities, and behavior. The main goal of the study is to find out whether this medication can help slow down or prevent the worsening of cognitive functions, which relate to memory, thinking, and understanding.
Who can participate:
- You must be 18 years or older
- You need to have a clinical diagnosis of Fahr’s disease or syndrome, confirmed by symptoms and specific findings on a CT scan
- Your CT scan must show bilateral calcifications of the basal ganglia, meaning calcium deposits on both sides of a specific brain area
- A family history suggesting the condition runs in families (inherited in an autosomal dominant way) can support your eligibility
- Having a known genetic mutation in one of the genes related to Primary Familial Brain Calcification can also support your diagnosis
Who cannot participate:
- People without a confirmed diagnosis of Fahr’s syndrome or Fahr’s disease
- Those outside the specified age range for the study
- Individuals who belong to vulnerable populations, such as those unable to give informed consent or in dependent situations
- Anyone who does not meet the specific health criteria established to ensure participant safety
What the trial involves:
This is a double-blind study, which means neither you nor the researchers will know whether you’re receiving the actual medication or a placebo (an inactive substance). This design helps ensure the results are accurate and unbiased. The trial lasts for 12 months.
When you join the study, you’ll have a CT scan of your head to assess the calcium deposits in your brain. You’ll then be randomly assigned to receive either Etidronate Disodium oral capsules (400 mg) or a placebo. Throughout the 12-month treatment period, researchers will regularly monitor several aspects of your health, including:
- Changes in cognitive functioning (thinking and memory)
- Mobility and movement abilities
- Psychiatric symptoms
- Daily functioning and independence
- Overall quality of life
- Brain calcification levels
At the end of the 12 months, final assessments will be conducted to evaluate the treatment’s effects. The primary focus is on whether the medication helped maintain or improve cognitive abilities.
About the investigational drug:
Etidronate is the medication being tested in this trial. It belongs to a class of drugs called bisphosphonates, which are commonly used to treat bone disorders. In this study, researchers want to see if Etidronate can help manage the abnormal calcium deposits in the brain and potentially slow cognitive decline. The medication works by inhibiting cells that break down bone tissue, which may help reduce abnormal calcification. You would take it orally in capsule form.
Summary
Currently, there is one active clinical trial for intracranial calcification, focused specifically on Fahr’s Disease. This trial is taking place in the Netherlands and represents an important step in finding potential treatments for this rare condition. The study is investigating Etidronate Disodium, a bisphosphonate medication, to see if it can help preserve cognitive function in patients with abnormal brain calcification. The trial uses a rigorous double-blind design over a 12-month period to carefully evaluate not only cognitive changes but also broader impacts on movement, mental health, daily functioning, and quality of life. For patients with this rare condition, participation in clinical trials like this one offers both the possibility of accessing experimental treatments and contributing to medical knowledge that could benefit others with the same diagnosis in the future.