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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329082
First Posted: May 24, 2006
Last Update Posted: October 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
May 19, 2006
May 24, 2006
October 7, 2009
May 2006
May 2008   (Final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 1 year ]
Safety and tolerability
Complete list of historical versions of study NCT00329082 on ClinicalTrials.gov Archive Site
  • To determine the plasma pharmacokinetics of LY2062430 [ Time Frame: 1 year ]
  • To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations [ Time Frame: 1 year ]
  • To evaluate the changes in thinking and memory [ Time Frame: 1 year ]
  • To determine the plasma pharmacokinetics of LY2062430
  • To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations
  • To evaluate the changes in thinking and memory
Not Provided
Not Provided
 
Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers
LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers
To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: LY2062430
    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
  • Drug: Placebo
    5: Placebo QW IV for 12 weeks
  • Experimental: 1
    Intervention: Drug: LY2062430
  • Experimental: 2
    Intervention: Drug: LY2062430
  • Experimental: 3
    Intervention: Drug: LY2062430
  • Experimental: 4
    Intervention: Drug: LY2062430
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided
 
Completed
25
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00329082
6649
H8A-MC-LZAJ
Yes
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2009