Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04975269
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
82 Years
Study:
NCT04975269
Study Brief:
Protocol Section:
NCT04975269