Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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The purposes of this study are to determine: The safety of LY450139 dihydrate and any side effects that might be associated with it. How much LY450139 dihydrate should be given and how long it may be detected in blood. To determine if LY450139 dihydrate may have an effect on a protein found in blood, called A beta. This protein is studied in subjects with Alzheimer's disease. To collect and store samples from blood and spinal fluid for research related to Alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to LY450139 or other medications. Length of study: Approximately 29 weeks. Number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits. At no cost, approximately 45 eligible participants will receive: Study medication Study-related diagnostic and laboratory evaluations

Official Title
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LY450139: Tolerability and Biomarker Assessment in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: LY450139 dihydrate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 50 years of age and diagnosed with mild to moderate probable Alzheimer's disease Fluent in reading and speaking English and have a reliable study partner (caregiver) (someone who is in frequent contact and can make sure study medication is being taken correctly). If currently treated with certain drugs for Alzheimer's disease, doses must be the same for at least the last 2 months prior to starting study drug. Exclusion Criteria: Cannot be currently using or require MAOI antidepressants (such as selegiline or Eldepryl(R)), antipsychotics, benzodiazepines, calcium channel blockers for heart disease, and propanolol. Cannot have a clinically significant and/or uncontrolled condition or other significant disease, including a condition requiring treatment with warfarin or heparin; or have had or currently have a peptic ulcer, reflux disease, or gastrointestinal (GI) bleeding.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY450139 dihydrate|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine levels of peptides in blood and spinal fluid that might relate to Alzheimer's disease |  |  | 
| Evaluate changes in thinking and memory |  |  | 
| Evaluate changes in daily living activities |  |  | 
| Determine levels of study drug in blood and spinal fluid |  |  |