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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04793659
Registration number
NCT04793659
Ethics application status
Date submitted
11/02/2021
Date registered
11/03/2021
Titles & IDs
Public title
Fasudil fOr redUcing elopemeNt and Spatial Disorientation
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Scientific title
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
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Secondary ID [1]
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WP-0512-001
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Universal Trial Number (UTN)
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Trial acronym
FOUND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oral Fasudil 90 mg/day
Treatment: Drugs - Oral Fasudil 180 mg/day
Treatment: Drugs - Oral Placebo
Experimental: Oral Fasudil 90 mg/day - 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).
Experimental: Oral Fasudil 180 mg/day - 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).
Placebo comparator: Oral Placebo - Placebo comparator arm to investigational drug (Fasudil 90 mg/day or 180 mg/day).
Treatment: Drugs: Oral Fasudil 90 mg/day
Oral tablet
Treatment: Drugs: Oral Fasudil 180 mg/day
Oral tablet
Treatment: Drugs: Oral Placebo
Oral tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase
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Assessment method [1]
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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.
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Timepoint [1]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [1]
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Change in Weekly Wandering Report - Community Version (WWR-C)
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Assessment method [1]
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The WWR-C is composed of targeted questions related to excess walking, spontaneous pacing, elopement, and wayfinding; it is designed to be assessed on a weekly basis by caregivers about subjects for whom they care. The WWR-C asks the caregiver to rate the subject's behavior for the previous week.
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Timepoint [1]
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Weekly during the 12 weeks of the Double-Blind period
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Secondary outcome [2]
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Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)
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Assessment method [2]
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The RAWS-CV is a 40-item tool with 6 subscales to assess wandering behaviors (eloping behaviors, negative outcomes, mealtime impulsivity, persistent walking, repetitive walking, and spatial disorientation), and a total score scale.
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Timepoint [2]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [3]
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Change in Mini Mental State Examination (MMSE)
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Assessment method [3]
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The MMSE is a 30-point questionnaire that is used to measure cognitive impairment.
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Timepoint [3]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [4]
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Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)
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Assessment method [4]
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The NPI-Q provides an assessment of dementia-related emotional behavioral symptomatology in routine clinical practice settings. Caregiver distress is also assessed.
The NPI-Q asks the assessor to rate the previous 30 days. At the Final Visit, the assessor will rate the NPI-Q for the 2-week period following the final dose. The scale is completed by the caregiver without input from the subject. All reasonable efforts should be made to ensure each NPI-Q for an individual subject is completed by the same caregiver to minimize inter-rater variability.
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Timepoint [4]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [5]
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Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
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Assessment method [5]
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The CMAI-C is a 37-item scale to systematically assess agitation.
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Timepoint [5]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [6]
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Center for Neurological Study-Lability Scale (CNS-LS)
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Assessment method [6]
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The CNS-LS is a 7-item questionnaire to assess perceived frequency of pseudobulbar affect episodes.
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Timepoint [6]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [7]
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Zarit Burden Interview (ZBI)
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Assessment method [7]
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The ZBI is a 22-item scale to assess caregiver burden.
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Timepoint [7]
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Week 6 and Week 12 of the Double-Blind period
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Secondary outcome [8]
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Adverse Events (AEs)
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Assessment method [8]
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Timepoint [8]
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Through study completion, up to 26 weeks
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Secondary outcome [9]
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Serious Adverse Events (SAEs)
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Assessment method [9]
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Timepoint [9]
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Through study completion, up to 26 weeks
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Secondary outcome [10]
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Change in blood pressure
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Assessment method [10]
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Timepoint [10]
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Through study completion, up to 26 weeks
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Secondary outcome [11]
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Change in blood parameters
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Assessment method [11]
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Hematology: white blood cell count, hemoglobin, hematocrit, platelet count
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Timepoint [11]
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Through study completion, up to 26 weeks
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Secondary outcome [12]
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Change in blood chemistry
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Assessment method [12]
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Blood chemistry: glucose, sodium, potassium, bicarbonate, blood urea nitrogen, creatinine, cystatin c
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Timepoint [12]
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Through study completion, up to 26 weeks
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Secondary outcome [13]
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Change in liver function
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Assessment method [13]
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Liver function tests: albumin, total bilirubin, direct bilirubin, ALP, AST, ALT, gamma glutamyl transferase, lactate dehydrogenase
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Timepoint [13]
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Through study completion, up to 26 weeks
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Secondary outcome [14]
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Change in urine contents
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Assessment method [14]
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Urinalysis (occult blood, protein)
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Timepoint [14]
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Through study completion, up to 26 weeks
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Secondary outcome [15]
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Change in heart rhythm
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Assessment method [15]
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12-lead Electrocardiogram (ECG) will be used to obtain a record of cardiac activity
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Timepoint [15]
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Through study completion, up to 26 weeks
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Secondary outcome [16]
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Change in body weight
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Assessment method [16]
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Timepoint [16]
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Through study completion, up to 26 weeks
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Secondary outcome [17]
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Change in body temperature
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Assessment method [17]
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Timepoint [17]
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Through study completion, up to 26 weeks
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Secondary outcome [18]
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Change in respiratory rate
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Assessment method [18]
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Timepoint [18]
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Through study completion, up to 26 weeks
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Secondary outcome [19]
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Columbia Suicide Severity Rating Scale (C-SSRS)
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Assessment method [19]
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The C-SSRS is an assessment used to identify immediate risk of suicide, and is completed following the patient interview, review of medical record(s) and/or consultation with family members and/or other professionals. While the C-SSRS is a detailed interview, the full interview is needed only if the initial screening questions about suicidal ideation and behavior are positive.
In subjects with severe cognitive impairment, i.e., so substantial as to interfere with an understanding of the concept of suicide, the C-SSRS may be omitted.
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Timepoint [19]
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Through study completion, up to 26 weeks
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Eligibility
Key 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.
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Minimum age
50
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/02/2022
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Modbury Hospital - Modbury
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Recruitment hospital [2]
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Barwon Geriatrics - Geelong
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Recruitment hospital [3]
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GV Health - Shepparton
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Recruitment hospital [4]
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Northeast Health Wangaratta - Wangaratta
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Recruitment hospital [5]
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Neurodegenerative Disorders Research - West Perth
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Recruitment postcode(s) [1]
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5092 - Modbury
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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3630 - Shepparton
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Recruitment postcode(s) [4]
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3677 - Wangaratta
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Recruitment postcode(s) [5]
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6005 - West Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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New Jersey
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Country [4]
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United States of America
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State/province [4]
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New Mexico
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Country [5]
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United States of America
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State/province [5]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Woolsey Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04793659
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04793659