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. DELPHIA
Sponsor: |
EISAI |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR9235 |
U.S. Govt. ID: |
NCT03467152 |
Contact: |
Evelyn Dominguez: 212-305-2371 / edd5@cumc.columbia.edu |
This is a 22-week treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 2 study to evaluate the efficacy, safety, and tolerability of the study drug E2027, in participants with Dementia with Lewy Bodies (DLB) Lewy Body Dementia - LBD. The main purpose of this research study is to find if a new drug called E2027 works in people who have DLB. People with DLB have impairment in their cognitive function (things like language, concentration, thinking, reasoning and memory). They may also have other symptoms affecting their movement and mental status. E2027 is an investigational study drug that is thought to cause an increase in levels of a brain chemical known as cyclic guanosine monophosphate (cGMP). cGMP is a substance involved in how cells communicate within the brain. Increasing cGMP levels in the brain may improve cognitive function. The purpose of this study is to assess the safety (symptoms and medical problems you may experience - known as side effects), and efficacy (how well the study drug treats DLB) of the study drug. If you decide to participate, you will take the study drug orally (by mouth) once a day.
This study is closed
Investigator
Lawrence Honig, MD, PhD
Are you between the ages of 50-85 (inclusive)? |
Yes |
No |
Do you have Dementia with Lewy Bodies (DLB)? |
Yes |
No |
Do you have a caregiver or informant who is willing to provide follow-up information? |
Yes |
No |