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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00329082
First received: May 19, 2006
Last updated: October 5, 2009
Last verified: October 2009

May 19, 2006
October 5, 2009
May 2006
May 2008   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate the changes in thinking and memory [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00329082
6649, H8A-MC-LZAJ
Yes
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

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