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

NCT00244322 | Completed Phase 2

• 2 other identifiers: 9097H6L-MC-LFAJ
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

Secondary Outcomes (4)

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

• Evaluate changes in thinking and memory

• Evaluate changes in daily living activities

• Determine levels of study drug in blood and spinal fluid

Interventions

LY450139 dihydrate DRUG

placebo DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

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, 92037, United States

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

Indianapolis, Indiana, 46202, United States

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

St Louis, Missouri, 63108, United States

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

Portland, Oregon, 97239, United States

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

Philadelphia, Pennsylvania, 19104, United States

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

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Portelius E, Dean RA, Gustavsson MK, Andreasson U, Zetterberg H, Siemers E, Blennow K. A novel Abeta isoform pattern in CSF reflects gamma-secretase inhibition in Alzheimer disease. Alzheimers Res Ther. 2010 Mar 29;2(2):7. doi: 10.1186/alzrt30.

  PMID: 20350302 DERIVED

• Fleisher AS, Raman R, Siemers ER, Becerra L, Clark CM, Dean RA, Farlow MR, Galvin JE, Peskind ER, Quinn JF, Sherzai A, Sowell BB, Aisen PS, Thal LJ. Phase 2 safety trial targeting amyloid beta production with a gamma-secretase inhibitor in Alzheimer disease. Arch Neurol. 2008 Aug;65(8):1031-8. doi: 10.1001/archneur.65.8.1031.

  PMID: 18695053 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: October 1, 2005
• Study Completion: December 1, 2006
• Last Updated: May 28, 2007

Record last verified: 2007-05

Locations

US (6)