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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04760860
Eligibility Criteria:
Inclusion Criteria:
* Men or women with the diagnosis of dementia with Lewy Bodies per 2017 DLB Consortium criteria.
* Baseline MOCA 18 or above. On stable AChEI and/or memantine treatment regimen for ≥4 weeks prior to baseline.
Exclusion Criteria:
* Subjects unwilling or unable to give informed consent
* No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
* Orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic on supine to sitting or standing, or a sitting blood pressure of ≤90/60.
* Clinically significant traumatic brain injury or post-traumatic stress disorder
* Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study
* Psychiatric comorbidities including major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neurology assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit. Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.
* Use of investigational drugs within 30 days before screening
* Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
* Use of doxazosin, alfuzosin, prazosin, or tamsulosin
* For female participant, pregnancy, or plans for child-bearing during study period
* Participant is restricted from traveling to and from the study site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
90 Years
Study:
NCT04760860
Study Brief:
Protocol Section:
NCT04760860