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OpenTrials
Completed

NCT Number: NCT00329082

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2062430

Drug
  • 100mg QW IV for 12 weeks
  • 100mg Q4W IV for 12 weeks
  • 400mg QW IV for 12 weeks
  • 400mg Q4W IV for 12 weeks

Placebo

Drug

5: Placebo QW IV for 12 weeks

Primary outcomes

  1. Safety and tolerability

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 24, 2006
Registry last updated
Oct 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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