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

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.
 
ClinicalTrials.gov Identifier: NCT00329082
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 19, 2006
First Posted Date  ICMJE May 24, 2006
Last Update Posted Date October 7, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)		 Safety and tolerability [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2006)		 Safety and tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers
Official Title  ICMJE LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers
Brief Summary To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2008)		 25
Original Enrollment  ICMJE
 (submitted: May 19, 2006)		 65
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00329082
Other Study ID Numbers  ICMJE 6649
H8A-MC-LZAJ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chief Medical Officer, Eli Lilly
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP