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OpenTrials
Completed

NCT Number: NCT00244322

Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease

The purposes of this study are to determine:

* The safety of LY450139 dihydrate and any side effects that might be associated with it. * How much LY450139 dihydrate should be given and how long it may be detected in blood. * To determine if LY450139 dihydrate may have an effect on a protein found in blood, called A beta. This protein is studied in subjects with Alzheimer's disease. * To collect and store samples from blood and spinal fluid for research related to Alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to LY450139 or other medications.

Length of study: Approximately 29 weeks.

Number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits.

At no cost, approximately 45 eligible participants will receive:

* Study medication * Study-related diagnostic and laboratory evaluations

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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 - 5hours, EST), or speak with your personal physician, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

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 probable Alzheimer's disease
  • Fluent in reading and speaking English and have a reliable study partner (caregiver) (someone who is in frequent contact and can make sure study medication is being taken correctly).
  • If currently treated with certain drugs for Alzheimer's disease, doses must be the same for at least the last 2 months prior to starting study drug.

Exclusion criteria

  • Cannot be currently using or require MAOI antidepressants (such as selegiline or Eldepryl(R)), antipsychotics, benzodiazepines, calcium channel blockers for heart disease, and propanolol.
  • Cannot have a clinically significant and/or uncontrolled condition or other significant disease, including a condition requiring treatment with warfarin or heparin; or have had or currently have a peptic ulcer, reflux disease, or gastrointestinal (GI) bleeding.

Treatment and study plan

LY450139 dihydrate

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability

Secondary outcomes

  1. Determine levels of peptides in blood and spinal fluid that might relate to Alzheimer's disease

  2. Evaluate changes in thinking and memory

  3. Evaluate changes in daily living activities

  4. Determine levels of study drug in blood and spinal fluid

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

LY450139: Tolerability and Biomarker Assessment in Subjects With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2005
Study completion
2006
First posted
Oct 26, 2005
Registry last updated
May 28, 2007

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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