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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

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY2062430 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers
Study Start Date : May 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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
Experimental: 2 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
Experimental: 3 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
Experimental: 4 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
Placebo Comparator: 5 Drug: Placebo
5: Placebo QW IV for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To determine the plasma pharmacokinetics of LY2062430 [ Time Frame: 1 year ]
  2. To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations [ Time Frame: 1 year ]
  3. To evaluate the changes in thinking and memory [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329082


Locations
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United States, Connecticut
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.
New Haven, Connecticut, United States, 06510
United States, District of Columbia
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.
Washington, District of Columbia, United States, 20007
United States, Indiana
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.
Indianapolis, Indiana, United States, 46202
United States, Missouri
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.
St Louis, Missouri, United States, 63108
United States, New York
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.
Rochester, New York, United States, 14603
United States, Pennsylvania
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, 19104
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00329082    
Other Study ID Numbers: 6649
H8A-MC-LZAJ
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders