What is the EXPEDITION 3 study?We understand that having issues with your memory and/or thought processes can be worrying. And it’s perfectly natural to want to think carefully about what to do next and discuss your options with your family. When you do, consider EXPEDITION 3 – a clinical research study looking at an investigational drug for mild Alzheimer’s disease (AD).
The study is planned to last 18 months, at the end of which is the option of an extension study for participants who show improvement during the main study.
Who can take part in EXPEDITION 3?If you’d like to participate in the EXPEDITION 3 study, the study team will assess your health and condition fully during a clinic visit to make sure you’re able to take part. And if you’re not, don’t worry – your doctor will help you consider other options.
To be eligible, you must have a friend, relative or loved one who spends at least 10 hours a week with you and who are able to accompany you to all clinic visits and answer questions about you.
What will taking part in EXPEDITION 3 involve?You’d attend at least 22 clinic visits (some visits may last for more than a day) to allow us to monitor your health and condition using assessments, such as:
- ECGs (a painless look at your heart)
- MRI scan (a painless way to take a picture of your brain)
- Questionnaires about your memory and/or thought processes
- Urine and blood tests
You’ll also need to have a PET scan (another painless brain scan using radioactive dye) or, if required, a lumbar puncture (a needle inserted into your lower spine to remove a small amount of spinal fluid) at the start and end of the study. The procedure you have will depend on what is available at the study site.
What type of study drug is involved?Half of the study participants will receive the study drug, and the other half will get a placebo (this contains no medicine and looks just like the study drug). At no time would you, your study partner, your doctor and the study team know which study group you are assigned to.
|Sponsor:||Eli Lilly and Company|
|Information provided by (Responsible Party):||Eli Lilly and Company|
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo|
|Length of Study:||18 months|
|Ages Eligible for Study:||55 Years to 90 Years|
|Genders Eligible for Study:||Both|
|Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.|
|Has a Modified Hachinski Ischemia Scale score of less than or equal to 4.|
|Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit.|
|Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form).|
|Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD.|
|Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening.|
|Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.|
|Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia.|
|Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years.|
|Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness.|
|Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment.|
|Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions.|
|Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments.|
|Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks.|
|Has a history of chronic alcohol or drug abuse/dependence within the past 5 years.|