Fasudil fOr redUcing elopemeNt and Spatial Disorientation

NCT04793659 | Completed Phase 2 FDA Drug

• 1 other identifier: WP-0512-001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 11

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. 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

Dementia

Keywords

Wandering Behavior; Dementia; Fasudil

Outcome Measures

Primary Outcomes (1)

• Change in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase

  The GIW is a variant of the 7-point Clinical Global Impression-Severity (CGI-S) scale and is used in FOUND specifically to obtain the investigator's overall assessment of severity of the subject's wandering behavior.

  Week 6 and Week 12 of the Double-Blind period

Secondary Outcomes (19)

• Change in Weekly Wandering Report - Community Version (WWR-C)

  Weekly during the 12 weeks of the Double-Blind period

• Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)

  Week 6 and Week 12 of the Double-Blind period

• Change in Mini Mental State Examination (MMSE)

  Week 6 and Week 12 of the Double-Blind period

• Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)

  Week 6 and Week 12 of the Double-Blind period

• Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

  Week 6 and Week 12 of the Double-Blind period

Study Arms (3)

Oral Fasudil 90 mg/day

EXPERIMENTAL

Subjects will receive a daily dose of 90 mg Fasudil for 42 days (open-label period 1). After Period 1 is complete, if the subject is a responder to Fasudil 90 mg/day, they will be randomized to either Fasudil 90 mg/day or a placebo for 6 weeks (double-blind period 1), then crossover to the other arm for 6 weeks (double-blind period 2).

Drug: Oral Fasudil 90 mg/day; Drug: Oral Placebo

Oral Fasudil 180 mg/day

EXPERIMENTAL

If the subject is a not a responder in the open-label period 1 but tolerated Fasudil 90 mg/day, they will be escalated to Fasudil 180 mg/day (open-label period 2) for 42 days. If the subject is a responder to Fasudil 180 mg/day, they are randomized to either Fasudil 180 mg/day for 42 days or a placebo (double-blind period 1), then crossover to the other arm for 6 weeks (double-blind period 2).

Drug: Oral Fasudil 180 mg/day; Drug: Oral Placebo

Oral Placebo

PLACEBO COMPARATOR

Placebo comparator arm to investigational drug (Fasudil 90 mg/day or 180 mg/day).

Drug: Oral Fasudil 90 mg/day; Drug: Oral Fasudil 180 mg/day; Drug: Oral Placebo

Interventions

Oral Fasudil 90 mg/day DRUG

Oral tablet

Oral Fasudil 90 mg/day; Oral Placebo

Oral Fasudil 180 mg/day DRUG

Oral tablet

Oral Fasudil 180 mg/day; Oral Placebo

Oral Placebo DRUG

Oral tablet

Oral Fasudil 180 mg/day; Oral Fasudil 90 mg/day; Oral Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Woolsey Pharmaceuticals: lead

Study Sites (11)

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Accel Research Sites

Lakeland, Florida, 33803, United States

Location

Lakes Research, LLC.

Miami Lakes, Florida, 33014, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, 87109, United States

Location

Re:Cognition Health

Fairfax, Virginia, 22031, United States

Location

Modbury Hospital

Modbury, South Australia, 5092, Australia

Location

Barwon Geriatrics

Geelong, Victoria, 3220, Australia

Location

GV Health

Shepparton, Victoria, 3630, Australia

Location

Northeast Health Wangaratta

Wangaratta, Victoria, 3677, Australia

Location

Neurodegenerative Disorders Research

West Perth, Western Australia, 6005, Australia

Location

MeSH Terms

Conditions

Dementia; Wandering Behavior

Interventions

fasudil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Periods 1 and 2 of the open-label phase will be unblinded. Periods 3 and 4 are double-blind crossover phases.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Combined Open-Label and Double-Blind, Placebo-Controlled Crossover

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: March 11, 2021
• Study Start: December 15, 2020
• Primary Completion: December 8, 2021
• Study Completion: February 11, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); AU (5)