Palm Beach Neurological Center is participating in a clinical research study to evaluate an investigational drug called “Delphia” for patients suffering from Dementia with Lewy Bodies. An investigational drug is not yet approved for use by the public. Doctors perform these studies to make sure it is safe and to see if it is helpful for patients with Dementia with Lewy Bodies. The purpose of the Delphia study is to see if the investigational medication might improve cognitive functions including memory, attention and language in patients with Dementia with Lewy Bodies.
Benefits of Delphia Investigational Drug
The Delphia Investigational drug is thought to cause an increase in a brain chemical known as guanosine monophosphate (cGMP). It is a substance that is involved in how cells communicate within the brain. An increase of cGMP levels in the brain may improve cognitive function.
Who is Eligible to Participate:
• Patients must be of the age 50-85
• Have probable Dementia with Lewy Bodies (DLB)
• Does not have a neurological condition contributing to cognitive impairment beyond that caused by DLB
• Must have a caregiver, family member or friend who can assist with the study by providing information about the patient.
Once a participant is qualified, they will need to visit the study site ten times, for up to 22 weeks for medical tests and assessments. Each visit can last up to three hours. The more visits, the longer the potential hours it will take.
The participant will be randomly placed into two treatment groups, one receiving the investigational drug and the other receiving a placebo. Each group takes the drug (or placebo) once per day either with or without food.
How Can I get Started?
Step 1: Contact our study coordinator. The study coordinator will give you information about the study and help determine if you might qualify.
Step 2: Give informed consent. A study doctor will explain that study procedures and its possible benefits and risks. The study doctor will also answer any questions you might have. To join our study, you must read and sign an informed consent document to show that you understand the study and what’s required.
Step 3: Find out if you are eligible. The study staff will ask some health questions and may do a medical evaluation to make sure that you meet the requirements for the study.