Fasudil fOr redUcing elopemeNt and Spatial Disorientation
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2

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.
    

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 caregiver support), subjects may live in another setting such as a
      group home, an assisted living unit, or in a long-term care facility, provided that a
      caregiver, formal or informal, has sufficient contact with the subject to permit accurate
      completion of the necessary assessments.

      Enrolled subjects will enter the Open-Label Phase and receive treatment with fasudil 90
      mg/day (30 mg three times daily [tid]) for 6 weeks in Open-Label Period 1. Responders (i.e.,
      subjects who improve 2 points or more on the GIW) will proceed to the Double-Blind Phase.
      Subjects in whom fasudil is well-tolerated (i.e. subjects with ≤ 2 drug-related AEs of mild
      intensity, no drug-related AEs of greater than mild intensity, and creatinine level of < 1.5
      mg/dL at all times during the period) and who do not respond will enter Open-Label Period 2,
      and be dosed with fasudil 180 mg/day (60 mg tid) for 6 weeks. Responders will proceed to the
      Double-Blind Phase and non-responders will move to the final post-treatment visit. In the
      Double-Blind Phase, subjects will receive treatment with either placebo or the dose they
      responded to in the Open-Label Phase (90 mg/day or 180 mg/day) for 6 weeks (Double-Blind
      Period 1), following which treatment assignment will be crossed over for 6 weeks
      (Double-Blind Period 2). A final post-treatment visit will occur 14 days after the last dose
      of study drug. Visits may be performed by qualified healthcare professionals at home or other
      care setting, or at a doctor's office/clinic. Interviews may be performed by telephone and/or
      telemedicine as appropriate.

      Study Endpoints:

      Primary:

      • The Global Impression of Wandering (GIW)

      Secondary:

        -  Weekly Wandering Report - Community Version (WWR-C)

        -  The Revised Algase Wandering Scale - Community Version (RAWS-CV)

        -  The Mini Mental State Examination (MMSE)

        -  The Neuropsychiatric Inventory-Questionnaire (NPI-Q)

        -  The Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

        -  The Center for Neurological Study-Lability Scale (CNS-LS)

        -  The Zarit Burden Interview (ZBI)

        -  Safety

        -  Tolerability
    

Intervention name(s): Oral Fasudil 90 mg/day; Oral Fasudil 180 mg/day; Oral Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet; Oral tablet; Oral tablet
Intervention MeSH terms: Fasudil; 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Combined Open-Label and Double-Blind, Placebo-Controlled Crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wandering Behavior; Dementia; Fasudil