A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: Dementia With Lewy Bodies
Age: Between 50 - 85 Years
Gender: Male or Female
Meet criteria for probable DLB
Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
If receiving AChEIs, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment-naive subjects can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
Must have an identified caregiver or informant who is willing and able to provide follow-up information on the subject throughout the course of the study.
Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any comorbidities detected by clinical assessment or MRI.
History of transient ischemic attacks or stroke within 12 months of Screening.
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder
Severe visual or hearing impairment that may interfere with the subject study assessments including cognitive testing.
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease.
Have thyroid stimulating hormone (TSH) above normal range.
Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (eg, in skull and cardiac devices other than those approved as safe for use in MRI scans).
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB on brain MRI at Screening.
Hypersensitivity to E2027 or any of the excipients.
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening.
Females who are breastfeeding or pregnant at Screening or Baseline