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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244322
• Other study ID #: 9097
• Secondary ID: H6L-MC-LFAJ
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2005
• Last updated: May 24, 2007
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• LY450139 dihydrate

• placebo

Locations

Country	Name	City	State
United States	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	Indianapolis	Indiana
United States	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	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	Philadelphia	Pennsylvania
United States	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	Portland	Oregon
United States	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	Saint Louis	Missouri
United States	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	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability
Secondary	Determine levels of peptides in blood and spinal fluid that might relate to Alzheimer's disease
Secondary	Evaluate changes in thinking and memory
Secondary	Evaluate changes in daily living activities
Secondary	Determine levels of study drug in blood and spinal fluid

External Links

•   Lilly Clinical Trial Registry