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Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
This study is ongoing, but not recruiting participants.
First Received: January 11, 2008   Last Updated: September 3, 2009   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00594568
  Purpose

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase inhibits the production of A-Beta amyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial, patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient's participation will last approximately two years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.


Condition Intervention Phase
Alzheimer's Disease
Drug: LY450139
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Rate of cognitive and functional decline in Alzheimer's disease over time. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sometime during the study, patients originally given placebo will be given LY450139. This may help show the effect of long term treatment. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • A chemical marker of AD in the blood which may be lowered by LY450139. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Energy usage (metabolism) seen on a brain scan called FDG-PET. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Brain size (volume) seen with AD on a brain scan called vMRI. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Amount of brain amyloid plaque seen in AD on a brain scan called AV-45-PET. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • A chemical marker (tau) known to be elevated in spinal fluid in AD. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • To measure levels of LY450139 and their effect on safety, chemical markers, and effectiveness. [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
  • Quality of life. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: LY450139
100 mg by mouth once a day for duration of study
2: Experimental Drug: LY450139
140 mg by mouth once a day for duration of study
3: Placebo Comparator Drug: placebo
Once a day for a blinded period of time

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for mild to moderate AD with Mini-Mental State Examination score of 16 through 26 at visit 1
  • Modified Hachinski Ischemia Scale score of less than or equal to 4
  • Geriatric Depression Scale score of less than or equal to 6
  • A magnetic resonance imaging (MRI) or computerized tomography (CT)scan in the last 2 years with no findings inconsistent with a diagnosis of Alzheimer's disease
  • If female must be without menstruation for at least 12 consecutive months or have had both ovaries removed.

Exclusion Criteria:

  • Is not capable of swallowing whole oral medication
  • Has serious or unstable illnesses
  • Does not have a reliable caregiver
  • Chronic alcohol or drug abuse within the past 5 years
  • Has ever had active vaccination for AD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594568

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
United States, Arizona
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Phoenix, Arizona, United States, 85006
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Sun City, Arizona, United States, 85351
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Tucson, Arizona, United States, 85741
United States, California
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San Diego, California, United States, 92103
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Lomita, California, United States, 90717
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Orange, California, United States, 92868
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Sacramento, California, United States, 95817
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Santa Monica, California, United States, 90404
United States, Connecticut
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Hamden, Connecticut, United States, 06518
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New Haven, Connecticut, United States, 06510
United States, District of Columbia
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Washington, District of Columbia, United States, 20057
United States, Florida
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Brooksville, Florida, United States, 34613
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Pompano Beach, Florida, United States, 33064
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Fort Myers, Florida, United States, 33912
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Fort Lauderdale, Florida, United States, 33308
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St Petersburg, Florida, United States, 33716
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West Palm Beach, Florida, United States, 33407
United States, Illinois
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Chicago, Illinois, United States, 60611
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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United States, Louisiana
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United States, Maryland
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United States, Massachusetts
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West Yarmouth, Massachusetts, United States, 02673
United States, Missouri
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St Louis, Missouri, United States, 63108
United States, New York
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United States, North Carolina
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United States, Ohio
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
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United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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United States, South Carolina
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United States, Utah
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United States, Vermont
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United States, Wisconsin
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Argentina
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Buenos Aires, Argentina, 1425
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Santa Fe, Argentina, S3000FWO
Australia, New South Wales
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Randwick, Sydney, New South Wales, Australia, 2013
Australia, South Australia
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Australia, Victoria
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Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Belgium
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Leuven, Belgium, 3000
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Antwerp, Belgium, 2020
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Aalst, Belgium, 9300
Canada
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Quebec, Canada, G1R 3X5
Canada, British Columbia
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Penticton, British Columbia, Canada, V2A5C8
Canada, Quebec
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Sherbrooke, Quebec, Canada, J1H1Z1
Chile
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Antofagasta, Chile
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Valdivia, Chile
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Santiago, Chile
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Santiago De Chile, Chile, 6640870
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Concepcion, Chile
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Vina Del Mar, Chile
Denmark
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Kobenhavn, Denmark, 2100
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Svendborg, Denmark, 4000
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Roskilde, Denmark, 4000
Finland
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Kuopio, Finland, 70210
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Mikkeli, Finland, 50100
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Oulu, Finland, 90229
France
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Toulouse, France, 31059
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Tours, France, 37044
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Nice, France, 06002
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Rennes, France, 35000
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Rouen, France, 76036
Germany
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Dresden, Germany, 01307
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Goettingen, Germany, 37075
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Hannover, Germany, 30559
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Muenchen, Germany, BY 80336
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Regensburg, Germany, D-93053
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Siegen, Germany, 57072
India
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Mangalore, India, 575002
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Chennai, India, 600003
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Hyderabaad, India, 400082
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Kolkatta, India, 700054
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Mumbai, India, 400050
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Thiruvananthapuram, India, 695011
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Tirupati, India, 517507
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Varanasi, India, 221005
Israel
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Ashkelon, Israel, 78306
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Beer Sheva, Israel, 84170
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Haifa, Israel, 31096
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Jerusalem, Israel, 91240
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Petah Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52661
Italy
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Milano, Italy, 20157
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Pisa, Italy, 56126
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Rome, Italy, 00153
Japan
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Fukui, Japan, 910-3113
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Kochi, Japan, 780-0842
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Kagawa, Japan, 761-0793
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Fukuoka, Japan, 770-8076
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Tokushima, Japan, 770-8076
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Osaka, Japan, 590-0018
Poland
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Poznan, Poland, 61-606
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Gdynia, Poland, 81-361
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Lodz, Poland, 92-216
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Lublin, Poland, 20-950
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Bialystok, Poland, 15402
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Warsaw, Poland, 02-507
South Africa
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Bellair, South Africa, 4094
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Bellville, South Africa, 7530
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Cape Town, South Africa, 7925
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George, South Africa, 6529
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Somerset West, South Africa, 7130
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Rosebank, South Africa, 2132
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Umhlanga, South Africa, 4319
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Johannesburg, South Africa, 1709
Spain
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Albacete, Spain, 2006
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Barakaldo, Spain, 48903
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Barcelona, Spain, 08014
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Madrid, Spain, 28034
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Plasencia, Spain, 10600
Sweden
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Stockholm, Sweden, 14186
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Molndal, Sweden, 43185
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Norrköping, Sweden, 60172
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Malmo, Sweden, 20502
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Uddevalla, Sweden, 45180
United Kingdom
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Belfast, United Kingdom, BT9 7BL
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Newcastle, United Kingdom, NE4 6BE
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Stoke-On-Trent, United Kingdom, ST4 6QG
United Kingdom, Banes
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Bath, Banes, United Kingdom, BA1 3NG
United Kingdom, Hants
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Southampton, Hants, United Kingdom, SO30 3JB
United Kingdom, Merseyside
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Liverpool, Merseyside, United Kingdom, L9 7LJ
United Kingdom, Scotland
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Glasgow, Scotland, United Kingdom, G20 0XA
United Kingdom, Wilts
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Swindon, Wilts, United Kingdom, SN1 4JU
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

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 7666, H6L-MC-LFAN, CTRI/2009/091/000090
Study First Received: January 11, 2008
Last Updated: September 3, 2009
ClinicalTrials.gov Identifier: NCT00594568     History of Changes
Health Authority: United States: Food and Drug Administration

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 November 30, 2009