Trial · NCT04793659
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 | |
| Secondary | Change in blood pressure | Through study completion, up to 26 weeks | |
| Secondary | Change in blood parameters | Through study completion, up to 26 weeks | Hematology: white blood cell count, hemoglobin, hematocrit, platelet count |
| Secondary | Change in blood chemistry | Through study completion, up to 26 weeks | Blood chemistry: glucose, sodium, potassium, bicarbonate, blood urea nitrogen, creatinine, cystatin c |
| Secondary | Change in liver function | Through study completion, up to 26 weeks | Liver function tests: albumin, total bilirubin, direct bilirubin, ALP, AST, ALT, gamma glutamyl transferase, lactate dehydrogenase |
| Secondary | Change in urine contents | Through study completion, up to 26 weeks | Urinalysis (occult blood, protein) |
| Secondary | Change in heart rhythm | Through study completion, up to 26 weeks | 12-lead Electrocardiogram (ECG) will be used to obtain a record of cardiac activity |
| Secondary | Change in body weight | Through study completion, up to 26 weeks | |
| Secondary | Change in body temperature | Through study completion, up to 26 weeks | |
| Secondary | Change in respiratory rate | Through study completion, up to 26 weeks | |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | Through study completion, up to 26 weeks | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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