Delphia Research Study for Dementia with Lewy bodies (DLB)
The study has been called ‘Delphia’, Delphia is an abbreviation and stands for ‘Dementia with Lewy bodies Phosphodiesterase Inhibitor Assessment’. The Delphia study will test an investigational medication to see if it might improve cognitive function, including attention, memory, and language in patients who have dementia with Lewy bodies (DLB).
What is the purpose of the study?
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.
What is Involved in this Study?
If you qualify and agree to be in this study, you will visit the study site for medical tests and assessments approximately 10 times for up to 22 weeks. Most visits will last from one to three hours, and two visits will last longer, potentially four to six hours. You will be randomly placed into one of two treatment groups. One group will receive the study drug, and the other group will receive a placebo. The placebo looks like the study drug, but contains no active ingredient. Neither you nor the study staff will know which group you are in.
· Demographics/Medical History Questions
· Physical examinations
· Vital signs, height and weight taken
· ECG (Electrocardiogram): An ECG measures the rhythm and electrical activity of your heart.
· Blood and Urine Collections
· Urine Drug Screen: A sample of urine will be taken and screened for any drugs that may be present.
· Pregnancy Testing: (only if you are a woman less than 60 years old and you did not have sterilization surgery, you must have a negative pregnancy test in order to take part in this study) At the screening visit a blood pregnancy test will be performed on females who can get pregnant. At the baseline visit, a urine pregnancy test will be performed.
· Optional genetic blood sample: If you agree, a further blood sample (about 6mL or 1 teaspoon) will be collected to understand how your genes affect response to treatment and/or your disease. There is a separate consent form to sign if you agree to this.
· Questionnaires and Interviews
· Magnetic Resonance Imaging (MRI) Scan
· Dopamine Transporter (DAT) Brain Imaging Scan or Cardiac MIBG Scan: The study doctor may ask you to have one of either of these scans in order to confirm that you have dementia with Lewy bodies. The DAT scan will image your brain, whilst the MIBG scan will image your heart. Both of these scans will use low doses of radiation to produce computer images of your brain (DAT) or heart (MIBG). Your study doctor will let you know if you need to have either of these scans.
Before the scan you will be given an injection (into a vein) of a radioactive marker. Any radioactive imaging markers that are approved for these scans can be used in the study.
· Cerebrospinal Fluid (CSF) Sampling: If you decide to participate in the CSF sub-study, you will be given a separate consent form that will describe the procedure and explain the possible disadvantages and risks of taking part.
Who is organizing and funding the research?
This study is being sponsored at this country and paid for by a pharmaceutical company called:
Eisai Inc., 100 Tice Blvd. Woodcliff Lake, NJ 07677 USA
You will receive a travel reimbursement in the amount of $75 for each visit, up to a total of $750. The study doctor and/or study staff can explain the procedures and requirements (e.g., receipts) for such payback. You will receive a parking pass at each clinic visit. You will not receive any other money or payments. Reimbursement will come via check.
- IRB Number: 1805643252
- Research Study Identifier: NCT03467152
- Principal Investigator: Jared Brosch, MD