Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00244322

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Drug: LY450139 dihydrate Drug: placebo	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: LY 450139

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	LY450139: Tolerability and Biomarker Assessment in Subjects With Mild to Moderate Alzheimer's Disease

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Safety and tolerability

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	October 2005
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244322

Locations

United States, California
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, 92037
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 - 5hours, 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 - 5hours, EST), or speak with your personal physician
Saint Louis, Missouri, United States, 63108
United States, Oregon
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, 97239
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 - 5hours, EST), or speak with your personal physician
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
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, United States, 98108

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	9097, H6L-MC-LFAJ
Study First Received:	October 24, 2005
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00244322 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009