Status:
COMPLETED
Fasudil fOr redUcing elopemeNt and Spatial Disorientation
Lead Sponsor:
Woolsey Pharmaceuticals
Conditions:
Dementia
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief 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. Fasu...
Detailed Description
The study population will consist of subjects with dementia and wandering behaviors of elopement and/or getting lost. While it is anticipated that most participants will be residing at home (with care...
Eligibility Criteria
Inclusion
- 50 to 90 years of age (inclusive).
- Diagnosis of dementia of any etiology.
- MMSE 9-24 (inclusive).
- Presence of one or both of the following wandering behaviors that in the opinion of the investigator, in consultation with caregiver, is at least of moderate severity (defined as clearly a wanderer, and this causes some distress or difficulty for both the subject and caregiver):
- Elopes or attempts to elope AND/OR
- Gets lost or is unable to locate a specific place.
- Independently ambulatory with or without assistive devices (such as canes or walkers). Subjects must not require assistance to transfer out of bed or a chair.
- Subject has a caregiver who has more than 10 hours/week of contact with the subject, is fluent and literate in English and is willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
- Consent obtained from the participant/legally authorized representative (LAR) in accordance with local regulations.
Exclusion
- Expected change in medication that could interfere with the study or free movement of the subject.
- Serum creatinine ≥ 1.5 mg/dL.
- ALT and/or alkaline aminotransferase (AST) ≥ 2 X and/or alkaline phosphatase (ALP) ≥ 1.5 upper limit of normal.
- Blood pressure \< 90/60.
- On more than one of the following drug classes: long-acting nitrates, beta-blockers, or calcium channel blockers.
- Any severe comorbidity that in the opinion of the Investigator would disallow safe participation in the trial.
- Women of child-bearing potential; females must be postmenopausal or surgically sterilized.
- Suicidal ideation per the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the opinion of the PI would pose a safety risk or interfere with the appropriate interpretation of study data.
- Planned change in the current living setting during the study.
- History within the last year of either two or more falls leading to clinically significant injuries or one or more fall leading to hospitalization, and/or evidence of orthostatic hypotension.
- Participation in another investigational drug study within 30 days before start of Open-Label period.
- Subjects who, in the opinion of the investigator, are not suitable for the study.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04793659
Start Date
December 15 2020
End Date
February 11 2022
Last Update
July 11 2022
Active Locations (11)
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1
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
2
Accel Research Sites
Lakeland, Florida, United States, 33803
3
Lakes Research, LLC.
Miami Lakes, Florida, United States, 33014
4
Bio Behavioral Health
Toms River, New Jersey, United States, 08755