Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00244322
First received: October 24, 2005
Last updated: May 24, 2007
Last verified: May 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | LY450139: Tolerability and Biomarker Assessment in Subjects With Mild to Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00244322 History of Changes |
| Other Study ID Numbers: | 9097, H6L-MC-LFAJ |
| Study First Received: | October 24, 2005 |
| Last Updated: | May 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013