Trial · NCT04793659
Fasudil fOr redUcing elopemeNt and Spatial Disorientation
NCT04793659, Phase 2, Completed, Woolsey Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fasudil fOr redUcing elopemeNt and Spatial Disorientation. Trials, record NCT04793659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04793659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fasudil fOr redUcing elopemeNt and Spatial Disorientation
- NCT number
- NCT04793659
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Woolsey Pharmaceuticals
- Conditions
- Dementia
- Interventions
- Oral Fasudil 90 mg/day, Oral Fasudil 180 mg/day, Oral Placebo
- First posted
- 2021-03-11
- Last updated
- 2022-07-11
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase | 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. |
| Secondary | Change in Weekly Wandering Report - Community Version (WWR-C) | Weekly during the 12 weeks of the Double-Blind period | 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. |
| Secondary | Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV) | Week 6 and Week 12 of the Double-Blind period | 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. |
| Secondary | Change in Mini Mental State Examination (MMSE) | Week 6 and Week 12 of the Double-Blind period | The MMSE is a 30-point questionnaire that is used to measure cognitive impairment. |
| Secondary | Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q) | Week 6 and Week 12 of the Double-Blind period | 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. |
| Secondary | Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) | Week 6 and Week 12 of the Double-Blind period | The CMAI-C is a 37-item scale to systematically assess agitation. |
| Secondary | Center for Neurological Study-Lability Scale (CNS-LS) | Week 6 and Week 12 of the Double-Blind period | The CNS-LS is a 7-item questionnaire to assess perceived frequency of pseudobulbar affect episodes. |
| Secondary | Zarit Burden Interview (ZBI) | Week 6 and Week 12 of the Double-Blind period | The ZBI is a 22-item scale to assess caregiver burden. |
| Secondary | Adverse Events (AEs) | Through study completion, up to 26 weeks | |
| Secondary | Serious Adverse Events (SAEs) | Through study completion, up to 26 weeks |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04793659
GET https://conductscience.org/api/trials/v1/NCT04793659/registered