Fasudil fOr redUcing elopemeNt and Spatial Disorientation

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia

In brief

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.

Key facts

Study ID

NCT04793659

Run by

Woolsey Pharmaceuticals

People needed

24

Starts

2020-12-15

Expected to finish

2022-02-11

Last updated by the study team

2022-07-11

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Accel Research Sites — Lakeland, Florida, United States
• Lakes Research, LLC. — Miami Lakes, Florida, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• Albuquerque Neuroscience Inc. — Albuquerque, New Mexico, United States
• Re:Cognition Health — Fairfax, Virginia, United States
• Modbury Hospital — Modbury, South Australia, Australia
• Barwon Geriatrics — Geelong, Victoria, Australia
• GV Health — Shepparton, Victoria, Australia
• Northeast Health Wangaratta — Wangaratta, Victoria, Australia
• Neurodegenerative Disorders Research — West Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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