Alzheimer's Disease
Conditions
Brief summary
To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.
Interventions
DRUGLY2062430
1. 100mg QW IV for 12 weeks 2. 100mg Q4W IV for 12 weeks 3. 400mg QW IV for 12 weeks 4. 400mg Q4W IV for 12 weeks
DRUGPlacebo
5: Placebo QW IV for 12 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 50 years of age and diagnosed with mild to moderate Alzheimer's disease or healthy volunteers * fluent in reading and speaking English * AD patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements * AD patients who have received AChEIs or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug
Exclusion criteria
* Have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years * Have serious or uncontrolled health problems or laboratory tests * Multiple or severe drug allergies * Prior participation in an active immunization study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine the plasma pharmacokinetics of LY2062430 | 1 year |
| To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations | 1 year |
| To evaluate the changes in thinking and memory | 1 year |
Countries
United States
Outcome results
None listed