Acetazolamide for Treating NPH in Shunt-candidates Patients
Keywords
Abstract
Dates
Last Verified: | 11/30/2018 |
First Submitted: | 12/09/2018 |
Estimated Enrollment Submitted: | 12/16/2018 |
First Posted: | 12/18/2018 |
Last Update Submitted: | 12/16/2018 |
Last Update Posted: | 12/18/2018 |
Actual Study Start Date: | 11/30/2018 |
Estimated Primary Completion Date: | 11/30/2019 |
Estimated Study Completion Date: | 11/30/2019 |
Condition or disease
Intervention/treatment
Drug: treatment group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: treatment group patients who met the inclusion criteria will be allocated to the treatment group, and will receive acetazolamide from time of diagnosis until shunt surgery (2-6 weeks). | Drug: treatment group Patients will be assign and treated by acetazolamide from time of allocation until surgery (2-6 weeks after treatment initiation). The maximal dose of acetazolamide will be the same dose used to treat glaucoma, considering similarity of patients' characteristics, such as age and polypharmacy. We will start at a low dose of 250 mg once a day, and increase it slowly to a maximal dose of 500 mg twice a day. Dose will be individualized according to side-effects and tolerability. Renal and liver function tests will be performed before initiation of treatment, and will be examined again two weeks after treatment had begun. |
Eligibility Criteria
Ages Eligible for Study | 50 Years To 50 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: Included will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both. 1. Are 50 years old or older. 2. Patients who meet the criteria for NPH based on: - A typical personal history. - A typical brain imaging on head CT or MRI. - Normal lumbar puncture findings excluding other conditions. - Exclusion of other more likely diagnosis. 3. Patients who underwent large-volume spinal tap and subsequently improved clinically by at least 10% in gait function or cognition. Exclusion Criteria: - Cirrhosis or marked liver disease or dysfunction. - Severe renal disease or dysfunction. - Acidosis. - Hypersensitivity to acetazolamide, sulfonamides, or any component of the formulation. - Decreased sodium and/or potassium levels. - Adrenocortical insufficiency. - Patients with cognitive impairment who will not be able to give informed consent. |
Outcome
Primary Outcome Measures
1. Change from Baseline Gait [Baseline, week 4]
2. Change from Baseline Balance [Baseline, week 4]
Secondary Outcome Measures
1. Change from Baseline concentration function [Baseline, week 4]
2. Change from Baseline visuospatial function [Baseline, week 4]
3. Change from Baseline verbal fluency [Baseline, week 4]
Other Outcome Measures
1. adverse effects [week 2-6]