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CompletedPhase 2Fasudil fOr redUcing elopemeNt and Spatial Disorientation
A Phase 2a Combined Open-Label and Double-Blind, Placebo-Controlled Crossover Study Assessing the Effectiveness, Safety, and Tolerability of Oral Fasudil in Subjects With Dementia and Wandering Behaviors of Elopement and/or Getting Lost
Lead sponsor
Asset
Fasudil
Listed sites
11
Recruiting sites
-
Enrollment
24
actual
Study population
Mixed / unspecified dementia
Key I/E criteria
•MMSE 9-24•Study partner/caregiver required
Primary endpoint
•Global Impression of Wandering (GIW) after oral Fasudil
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 50 to 90 years of age (inclusive).
2. Diagnosis of dementia of any etiology.
3. MMSE 9-24 (inclusive).
4. 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):
1. Elopes or attempts to elope AND/OR
2. Gets lost or is unable to locate a specific place.
5. 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.
6. 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.
7. Consent obtained from the participant/legally authorized representative (LAR) in accordance with local regulations
Exclusion criteria
1. Expected change in medication that could interfere with the study or free movement of the subject.
2. Serum creatinine ≥ 1.5 mg/dL.
3. ALT and/or alkaline aminotransferase (AST) ≥ 2 X and/or alkaline phosphatase (ALP) ≥ 1.5 upper limit of normal.
4. Blood pressure < 90/60.
5. On more than one of the following drug classes: long-acting nitrates, beta-blockers, or calcium channel blockers.
6. Any severe comorbidity that in the opinion of the Investigator would disallow safe participation in the trial.
7. Women of child-bearing potential; females must be postmenopausal or surgically sterilized.
8. 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.
9. Planned change in the current living setting during the study.
10. 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.
11. Participation in another investigational drug study within 30 days before start of Open-Label period.
12. Subjects who, in the opinion of the investigator, are not suitable for the study.
Endpoints (20)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChange in Mini Mental State Examination (MMSE)
Time frame:Week 6 and Week 12 of the Double-Blind period
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Behavior / neuropsychiatric
6 endpointsChange in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase
Time frame:Week 6 and Week 12 of the Double-Blind period
change from baseline, improvement
Change in Weekly Wandering Report - Community Version (WWR-C)
Time frame:Weekly during the 12 weeks of the Double-Blind period
change from baseline, improvement
Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)
Time frame:Week 6 and Week 12 of the Double-Blind period
change from baseline, improvement
Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Time frame:Week 6 and Week 12 of the Double-Blind period
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Time frame:Week 6 and Week 12 of the Double-Blind period
descriptive
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:Through study completion, up to 26 weeks
descriptive
Caregiver / quality of life
1 endpointZarit Burden Interview (ZBI)
Time frame:Week 6 and Week 12 of the Double-Blind period
descriptive
Safety / tolerability / PK
3 endpointsAdverse Events (AEs)
Time frame:Through study completion, up to 26 weeks
event count, event
Serious Adverse Events (SAEs)
Time frame:Through study completion, up to 26 weeks
event count, event
Change in heart rhythm
Time frame:Through study completion, up to 26 weeks
change from baseline, event
Other clinical outcomes
1 endpointChange in blood pressure
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Other (unclassified)
8 endpointsCenter for Neurological Study-Lability Scale (CNS-LS)
Time frame:Week 6 and Week 12 of the Double-Blind period
event count, event
Change in blood parameters
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in blood chemistry
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in liver function
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in urine contents
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in body weight
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in body temperature
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Change in respiratory rate
Time frame:Through study completion, up to 26 weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.