Fasudil fOr redUcing elopemeNt and Spatial Disorientation
NCT04793659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-07-11
Summary
Fasudil, a Rho kinase inhibitor, is believed to reduce wandering behaviors of elopement and getting lost by improving spatial memory and navigation through improvements in hippocampal blood flow. Fasudil is non-sedating.
The aim of the study is to assess the effectiveness of oral fasudil in reducing wandering behaviors of elopement and/or getting lost in subjects with dementia. In addition, effects on wandering behaviors of excess movement and pacing, cognition, memory, neuropsychiatric symptomatology, caregiver/nursing staff burden, and the safety and tolerability of fasudil treatment will be assessed.
Conditions
Interventions
- DRUG
-
Oral Fasudil 90 mg/day
Oral tablet
- DRUG
-
Oral Fasudil 180 mg/day
Oral tablet
- DRUG
-
Oral Placebo
Oral tablet
Sponsors & Collaborators
-
Woolsey Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 50 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-15
- Primary Completion
- 2021-12-08
- Completion
- 2022-02-11
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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