Acetazolamide Trial in Normal Pressure Hydrocephalus

Launched by UPPSALA UNIVERSITY HOSPITAL · Jul 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called acetazolamide on patients with a condition known as idiopathic normal pressure hydrocephalus (INPH). INPH is a brain condition that can affect walking, balance, and cognitive function. The main goal of the trial is to see if acetazolamide can help improve walking ability in patients before they undergo a procedure called shunt surgery. Participants in the trial will either receive acetazolamide or a placebo (a substance with no active ingredients) for the duration of their treatment.

To be eligible for the trial, participants must be between the ages of 50 and 82 and have a diagnosis of INPH based on specific guidelines. They should also have a certain level of cognitive function and meet specific MRI criteria related to their condition. The trial is currently recruiting 42-50 patients and is designed to be double-blind, meaning that neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are reliable. It's important to note that patients will need to be able to take the medication independently and meet other health criteria to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of idiopathic normal pressure hydrocephalus according to international guidelines
• • 2. Age ≥ 50 years and ≤ 82 years
• • 3. Cognitive function with Mini-Mental State Examination \> 20 points or cognitive domain of iNPH scale ≥ 30 points.
• • 4. MRI image characteristic of normal pressure hydrocephalus, defined as callosal angle \< 90 degrees and dilated lateral ventricles or pattern of disproportionately enlarged subarachnoid space hydrocephalus (DESH).
• • 5. Signed informed consent form
• Exclusion Criteria:
• • 1. Exclusion criteria for MRI examination
• • 2. Participation in another medical trial
• • 3. Other disease likely to impact the symptoms of the patient
• • 4. Wheelchair user or unable to walk without support
• • 5. Reduced kidney function with GFR \< 50
• • 6. Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)
• • 7. Known heart failure
• • 8. Low concentrations of electrolytes in blood plasma that, according to the investigator, prevents participation in the study
• • 9. Angle-closure glaucoma
• • 10. Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
• • 11. Treatment with phenytoin, valproate, carbamazepine, lithium, oral anticoagulants, thiazide-diuretics, or acetylsalicylic acid \> 100 mg/day
• • 12. Inability to swallow capsules of the same size as the investigational medicinal products (will be tested using empty capsules when the patient is asked to participate in the study)
• • 13. Average walking time for the three walking tests \< 10.5 seconds for men and \< 11.5 seconds for women.
• • 14. Average walking time for the three walking tests \> 50 seconds
• • 15. Inability to comply with the study treatment independently, and a concurrent lack of individuals to help the patient comply with the treatment during the study period
• • 16. Fertile woman without highly effective contraception. A Fertile woman will be tested with pregnancy test before inclusion is possible.