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
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: LY2062430
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329082

Locations
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
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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00329082     History of Changes
Other Study ID Numbers: 6649, H8A-MC-LZAJ
Study First Received: May 19, 2006
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014