Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT04793659
Eligibility Criteria:
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.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT04793659
Study Brief:
Protocol Section:
NCT04793659