Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: LY2062430; Drug: Placebo

• Registration Number: NCT00329082
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-24
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Disposition First Submitted: 2009-06-10
• Status Verified: 2009-10
• Disposition First Submitted QC: 2009-10-05
• Last Update Submitted: 2009-10-05
• Disposition First Posted: 2009-10-07
• Last Update Posted: 2009-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	LY2062430	-
5	Placebo	-
1	LY2062430	-
3	LY2062430	-
2	LY2062430	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Philadelphia, Pennsylvania, United States