DementiaPhase 2FOUNDNCT04793659
Fasudil fOr redUcing elopemeNt and Spatial Disorientation
A Phase 2 study testing Oral Fasudil 90 mg/day and Oral Fasudil 180 mg/day in people with Dementia, run by Woolsey Pharmaceuticals at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Dementia
- What is being tested?
- Oral Fasudil 90 mg/day and Oral Fasudil 180 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 15 Dec 2020to 11 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States6 sites
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
Re:Cognition Health
Fairfax, Virginia, 22031
Accel Research Sites
Lakeland, Florida, 33803
Lakes Research, LLC.
Miami Lakes, Florida, 33014
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Bio Behavioral Health
Toms River, New Jersey, 08755
Australia5 sites
Barwon Geriatrics
Geelong, Victoria, 3220
Modbury Hospital
Modbury, South Australia, 5092
GV Health
Shepparton, Victoria, 3630
Northeast Health Wangaratta
Wangaratta, Victoria, 3677
Neurodegenerative Disorders Research
West Perth, Western Australia, 6005
About this study
Official 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
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.
Read the 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
- Conditions
- Dementia
- Being tested
- Oral Fasudil 90 mg/day, Oral Fasudil 180 mg/day, Oral Placebo
- Keywords
- Wandering Behavior, Dementia, Fasudil
- Medical subject headings
- Dementia, Wandering Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Fasudil 90 mg/dayDrug
Oral tablet
Oral Fasudil 180 mg/dayDrug
Oral tablet
Oral PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Oral Fasudil 90 mg/day; Drug: Oral Fasudil 180 mg/day; Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6 and Week 12 of the Double-Blind period
Secondary outcomes (19)
Change in Weekly Wandering Report - Community Version (WWR-C)
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.
Measured: Weekly during the 12 weeks of the Double-Blind period
Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)
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.
Measured: Week 6 and Week 12 of the Double-Blind period
Change in Mini Mental State Examination (MMSE)
The MMSE is a 30-point questionnaire that is used to measure cognitive impairment.
Measured: Week 6 and Week 12 of the Double-Blind period
Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)
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.
Measured: Week 6 and Week 12 of the Double-Blind period
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
The CMAI-C is a 37-item scale to systematically assess agitation.
Measured: Week 6 and Week 12 of the Double-Blind period
Center for Neurological Study-Lability Scale (CNS-LS)
The CNS-LS is a 7-item questionnaire to assess perceived frequency of pseudobulbar affect episodes.
Measured: Week 6 and Week 12 of the Double-Blind period
Zarit Burden Interview (ZBI)
The ZBI is a 22-item scale to assess caregiver burden.
Measured: Week 6 and Week 12 of the Double-Blind period
Adverse Events (AEs)
Measured: Through study completion, up to 26 weeks
Serious Adverse Events (SAEs)
Measured: Through study completion, up to 26 weeks
Change in blood pressure
Measured: Through study completion, up to 26 weeks
Change in blood parameters
Hematology: white blood cell count, hemoglobin, hematocrit, platelet count
Measured: Through study completion, up to 26 weeks
Change in blood chemistry
Blood chemistry: glucose, sodium, potassium, bicarbonate, blood urea nitrogen, creatinine, cystatin c
Measured: Through study completion, up to 26 weeks
Change in liver function
Liver function tests: albumin, total bilirubin, direct bilirubin, ALP, AST, ALT, gamma glutamyl transferase, lactate dehydrogenase
Measured: Through study completion, up to 26 weeks
Change in urine contents
Urinalysis (occult blood, protein)
Measured: Through study completion, up to 26 weeks
Change in heart rhythm
12-lead Electrocardiogram (ECG) will be used to obtain a record of cardiac activity
Measured: Through study completion, up to 26 weeks
Change in body weight
Measured: Through study completion, up to 26 weeks
Change in body temperature
Measured: Through study completion, up to 26 weeks
Change in respiratory rate
Measured: Through study completion, up to 26 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Through study completion, up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start15 Dec 2020
- Primary completion8 Dec 2021
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Combined Open-Label and Double-Blind, Placebo-Controlled Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woolsey Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793659
- Sponsor's protocol ID
- WP-0512-001
- Acronym
- FOUND
- Status last verified
- Jul 2022
- First submitted
- 11 Feb 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04793659
- Acronym / sponsor ID
- FOUND / WP-0512-001
- Conditions
- Dementia
- Keywords
- Wandering Behavior, Dementia, Fasudil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Woolsey PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Combined Open-Label and Double-Blind, Placebo-Controlled Crossover
| Arm | Type | Receives |
|---|---|---|
| Oral Fasudil 90 mg/day | Experimental | Drug: Oral Fasudil 90 mg/day, Drug: Oral PlaceboSubjects 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). |
| Oral Fasudil 180 mg/day | Experimental | Drug: Oral Fasudil 180 mg/day, Drug: Oral PlaceboIf 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). |
| Oral Placebo | Placebo comparator | Drug: Oral Fasudil 90 mg/day, Drug: Oral Fasudil 180 mg/day, Drug: Oral PlaceboPlacebo comparator arm to investigational drug (Fasudil 90 mg/day or 180 mg/day). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 50 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):
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Fasudil 90 mg/dayOral tablet | Drug | Oral Fasudil 90 mg/day, Oral Placebo |
| Oral Fasudil 180 mg/dayOral tablet | Drug | Oral Fasudil 180 mg/day, Oral Placebo |
| Oral PlaceboOral tablet | Drug | Oral Fasudil 180 mg/day, Oral Fasudil 90 mg/day, Oral Placebo |
Primary outcome
Change 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
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.
19 secondary outcomes
Change in Weekly Wandering Report - Community Version (WWR-C)
Time frame: Weekly during the 12 weeks of the Double-Blind period
Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV)
Time frame: Week 6 and Week 12 of the Double-Blind period
Change in Mini Mental State Examination (MMSE)
Time frame: Week 6 and Week 12 of the Double-Blind period
Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Time frame: Week 6 and Week 12 of the Double-Blind period
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Time frame: Week 6 and Week 12 of the Double-Blind period
Center for Neurological Study-Lability Scale (CNS-LS)
Time frame: Week 6 and Week 12 of the Double-Blind period
Zarit Burden Interview (ZBI)
Time frame: Week 6 and Week 12 of the Double-Blind period
Adverse Events (AEs)
Time frame: Through study completion, up to 26 weeks
Serious Adverse Events (SAEs)
Time frame: Through study completion, up to 26 weeks
Change in blood pressure
Time frame: Through study completion, up to 26 weeks
Change in blood parameters
Time frame: Through study completion, up to 26 weeks
Change in blood chemistry
Time frame: Through study completion, up to 26 weeks
Change in liver function
Time frame: Through study completion, up to 26 weeks
Change in urine contents
Time frame: Through study completion, up to 26 weeks
Change in heart rhythm
Time frame: Through study completion, up to 26 weeks
Change in body weight
Time frame: Through study completion, up to 26 weeks
Change in body temperature
Time frame: Through study completion, up to 26 weeks
Change in respiratory rate
Time frame: Through study completion, up to 26 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Through study completion, up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Fasudil 90 mg/day and Oral Fasudil 180 mg/day in people with Dementia, run by Woolsey Pharmaceuticals at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.