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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00765115 |
To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated subjects.
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease |
Drug: LY450139 Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects |
Enrollment: | 27 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
100 mg LY 450139 oral
|
Drug: LY450139 |
2: Experimental
140 mg LY450139 oral
|
Drug: LY450139 |
3: Experimental
280 mg LY450139 oral
|
Drug: LY450139 |
4: Experimental
Placebo
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Drug: placebo |
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
For additional information regarding investigtive sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
St. Louis, Missouri, United States, 63130 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Office ) |
Study ID Numbers: | 9384, H6L-MC-LFAM |
Study First Received: | September 30, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00765115 |
Health Authority: | United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |