Delphia study
Research type
Research Study
Full title
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)
IRAS ID
244573
Contact name
Dag Aarsland
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2017-003728-64
Duration of Study in the UK
1 years, 6 months, 16 days
Research summary
The main purpose of this research study is to find if a new drug called E2027 works in people who have Dementia with Lewy bodies (DLB). DLB is a neurodegenerative dementia with visual hallucinations, parkinsonism, sleep disorders, and other symptoms. People with DLB have impairment in their cognitive function (things like language, concentration, thinking, reasoning and memory).
The purpose of this study is to assess the safety (symptoms and medical problems that the patient may experience - known as side effects), and efficacy (how well the study drug treats DLB) of the study drug.
Approximately 182 patients will take part in this study in about 60 research centres in North America, Europe, and Japan. We expect that the entire study will take about 2 years to complete.REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0151
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion