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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
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
Secondary ID [1] 0 0
WP-0512-001
Universal Trial Number (UTN)
Trial acronym
FOUND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase
Timepoint [1] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [1] 0 0
Change in Weekly Wandering Report - Community Version (WWR-C)
Timepoint [1] 0 0
Weekly during the 12 weeks of the Double-Blind period
Secondary outcome [2] 0 0
Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)
Timepoint [2] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [3] 0 0
Change in Mini Mental State Examination (MMSE)
Timepoint [3] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [4] 0 0
Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Timepoint [4] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [5] 0 0
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Timepoint [5] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [6] 0 0
Center for Neurological Study-Lability Scale (CNS-LS)
Timepoint [6] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [7] 0 0
Zarit Burden Interview (ZBI)
Timepoint [7] 0 0
Week 6 and Week 12 of the Double-Blind period
Secondary outcome [8] 0 0
Adverse Events (AEs)
Timepoint [8] 0 0
Through study completion, up to 26 weeks
Secondary outcome [9] 0 0
Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Through study completion, up to 26 weeks
Secondary outcome [10] 0 0
Change in blood pressure
Timepoint [10] 0 0
Through study completion, up to 26 weeks
Secondary outcome [11] 0 0
Change in blood parameters
Timepoint [11] 0 0
Through study completion, up to 26 weeks
Secondary outcome [12] 0 0
Change in blood chemistry
Timepoint [12] 0 0
Through study completion, up to 26 weeks
Secondary outcome [13] 0 0
Change in liver function
Timepoint [13] 0 0
Through study completion, up to 26 weeks
Secondary outcome [14] 0 0
Change in urine contents
Timepoint [14] 0 0
Through study completion, up to 26 weeks
Secondary outcome [15] 0 0
Change in heart rhythm
Timepoint [15] 0 0
Through study completion, up to 26 weeks
Secondary outcome [16] 0 0
Change in body weight
Timepoint [16] 0 0
Through study completion, up to 26 weeks
Secondary outcome [17] 0 0
Change in body temperature
Timepoint [17] 0 0
Through study completion, up to 26 weeks
Secondary outcome [18] 0 0
Change in respiratory rate
Timepoint [18] 0 0
Through study completion, up to 26 weeks
Secondary outcome [19] 0 0
Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [19] 0 0
Through study completion, up to 26 weeks

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.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/02/2022
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Modbury Hospital - Modbury
Recruitment hospital [2] 0 0
Barwon Geriatrics - Geelong
Recruitment hospital [3] 0 0
GV Health - Shepparton
Recruitment hospital [4] 0 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [5] 0 0
Neurodegenerative Disorders Research - West Perth
Recruitment postcode(s) [1] 0 0
5092 - Modbury
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3630 - Shepparton
Recruitment postcode(s) [4] 0 0
3677 - Wangaratta
Recruitment postcode(s) [5] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New Mexico
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Woolsey Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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