Clinical Trials for Normal Pressure Hydrocephalus
There are currently 2 ongoing clinical trials investigating treatment approaches for normal pressure hydrocephalus. These studies are exploring how imaging techniques and medications might help improve understanding and management of this condition, which affects fluid circulation in the brain and can cause walking difficulties, memory problems, and bladder control issues.
Clinical trial locations
- Sweden
Study on Gadobutrol for Patients with Idiopathic Normal Pressure Hydrocephalus to Understand Cerebrospinal Fluid Movement Using MRI
This trial is investigating how cerebrospinal fluid moves in the brain using advanced imaging techniques. The study uses a contrast agent called Gadovist (containing gadobutrol), which is injected into the spinal canal to make the fluid visible on MRI scans.
Who can participate:
- Adults aged 18 years or older, both men and women
- Patients being investigated for suspected idiopathic normal pressure hydrocephalus
Who cannot participate:
- Patients with known disorders affecting cerebrospinal fluid circulation
- Patients who are not comfortable with repeated MRI scans
- Patients who have had previous adverse reactions to Gadovist
- Patients who belong to vulnerable populations requiring special protection
What the trial involves: Participants will receive an injection of Gadovist into the spinal canal, followed by a series of MRI scans at different times. These scans will track how the contrast agent moves through the brain and how quickly it is eliminated from the body. The study aims to better understand the dynamics of cerebrospinal fluid movement, which could lead to improved treatment approaches in the future. Researchers will also monitor participants for any side effects from the contrast agent.
The trial is being conducted in Sweden.
Study on the Effects of Acetazolamide in Patients with Normal Pressure Hydrocephalus
This trial is examining whether acetazolamide, a medication that reduces fluid production in the body, can help improve walking ability in people with normal pressure hydrocephalus. The study compares the effects of acetazolamide with a placebo (an inactive capsule) over a period of up to nine months.
Who can participate:
- Adults aged 50 to 82 years
- Diagnosed with idiopathic normal pressure hydrocephalus according to international guidelines
- Mental ability score of at least 20 points on the Mini-Mental State Examination or 30 points or more on the cognitive domain of the iNPH scale
- Specific brain scan findings showing features consistent with the condition
- Able to provide informed consent
Who cannot participate:
- Patients unable to walk or with severe walking difficulties from causes other than normal pressure hydrocephalus
- Patients with other serious medical conditions that could interfere with the study
- Pregnant or breastfeeding women
- Patients unable to understand and consent to the study
- Patients currently participating in another clinical trial
What the trial involves: This is a double-blind study, meaning neither participants nor researchers will know who receives the actual medication or the placebo. Participants will be randomly assigned to one of these groups. Throughout the study, various assessments will measure changes in walking ability, including timed walking tests and evaluating quality of life through questionnaires. Additional evaluations include brain MRI scans to analyze changes in specific brain areas, and collection of blood and cerebrospinal fluid samples to study proteins related to the condition. The main focus is to determine whether acetazolamide can improve walking and overall symptoms.
The trial is being conducted in Sweden and is expected to conclude by July 15, 2025.
Summary
Both ongoing clinical trials for normal pressure hydrocephalus are being conducted in Sweden. One trial focuses on improving our understanding of how cerebrospinal fluid moves in the brain using imaging technology with the contrast agent Gadovist. The other trial investigates whether acetazolamide can provide therapeutic benefits by improving walking ability in patients.
These studies take different approaches to addressing the condition: one is diagnostic in nature, aiming to better visualize and understand the disease process, while the other tests a potential treatment option. Both trials require participants to meet specific age and diagnostic criteria, and both involve MRI scanning as part of the evaluation process. The research may contribute valuable insights into managing this challenging condition that affects walking, memory, and bladder control in older adults.
