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This is a clinical research study sponsored by Eli Lilly to evaluate the investigational study drug LY450139 for people with mild to moderate Alzheimer’s disease (AD) to find out if it will help slow the progression of disease.
Who is eligible to participate?
- People who are at least 55 years old (and if female, postmenopausal) without unstable illness
- People WITH mild to moderate probable AD
- People with a reliable caregiver who is in contact at least 10 hours per week and can accompany the participant to the study visits
- People who do not have difficulty communicating with site personnel
- People who can swallow whole oral medications
What happens at the visit?
Participation is voluntary and involves approximately 20 visits over the course of 22 months. Visits may include the following: gathering medical, medication and demographic information, physical, neurological and cognitive examinations, answering questionnaires, venipuncture for lab specimens (13 visits), electrocardiograms, urine specimens and safety/compliance monitoring. Extra visits may be added as needed for safety evaluation. Participants may also choose whether or not to participate in additional study addenda, like radiology imaging or spinal taps.
Participants will be asked to:
- Provide background information about their medical history, including date of last CAT head scan or head MRI
- Undergo physical, neurological, and cognitive examinations
- Have blood samples taken and have their blood pressure, height, and weight measured
- Complete a series of paper and pencil measures of memory, problem solving, and language
What are the benefits of participating?
- The information gained from this study will help investigators better understand the use of the study drug LY450139 as a possible treatment for mild to moderate AD
- There may be possible benefits for future people with mild to moderate AD from the information gathered during the course of the study
- With your permission, we can share results of your brain scans and your lab specimens with your doctor.
- Free parking and meals for visits longer than 3 hours will be provided.
Where is the study taking place?
All study visits will take place in the General Clinical Research Center (GCRC) at Boston University Medical Center. Parking in the Doctor’s Office Building garage at the hospital will be complimentary. If extenuating circumstances prevent you from finding transportation to the visit, special arrangements may be made.
How can I find out more?
If you are interested in participating in this study, please contact Stephanie Sikora at 617-414-1078 or sasikora@bu.edu.
Key Personnel
Anil Nair, MD (Principal Investigator)
Carol Rossi, RN (Clinical Research Manager)
Sumati Raghavan, MBBS, MD (Research Coordinator)
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