Trial record 1 of 1 for:    NCT00594568
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Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00594568
First received: January 11, 2008
Last updated: August 9, 2011
Last verified: July 2011
  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 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 lowers the production of beta amyloid. Semagacestat (LY450139) is a functional gamma-secretase inhibitor and was shown to lower beta amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were at a certain point in the study switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately two years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from LFAN (and another similar study LFBC) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFAN, LFBC and open label LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.


Condition Intervention Phase
Alzheimer's Disease
Drug: LY450139
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Change in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog11) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog11) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8 weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8 weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A change in amyloid beta plasma concentration [ Time Frame: Baseline (randomization), 6 weeks, 12 weeks, 52 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in positron emission tomography (PET) using fluorine-18 fluorodeoxyglucose (FDG-PET) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in amyloid imaging positron emission tomography (AV-45) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • A change in tau concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Clearance and volume of distribution of LY450139 will be reported [ Time Frame: 6 weeks, 12 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog12) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog14) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating (Sum of Boxes) (CDR-SB) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Neuropsychiatric Inventory (NPI) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Mini Mental State Examination (MMSE) during treatment [ Time Frame: Baseline (randomization), 52 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in EuroQol 5-Dimensional Health-related Quality of Life scale (EQ-5D) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Resource Utilization in Dementia-Lite (RUD-Lite) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog12) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8 weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog 14) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8 weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Clinical Dementia Rating (Sum of the Boxes) (CDR-SB) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Neuropsychiatric Inventory (NPI) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Mini Mental state Examination (MMSE) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in EuroQol 5-Dimensional Health-related Quality of Life scale (EQ-5D) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Resource Utilization in Dementia-Lite (RUD-Lite) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • A change in phospho-tau concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • A change in amyloid beta 42 concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: March 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg LY450139 Drug: LY450139
Administered orally once daily for duration of study
Other Name: semagacestat
Experimental: 140 mg LY450139 Drug: LY450139
Administered orally once daily for duration of study
Other Name: semagacestat
Placebo Comparator: Placebo Drug: placebo
Administered orally once daily for duration of study

  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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Fresno, California, United States, 93720
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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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San Diego, California, United States, 92103
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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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Fort Lauderdale, Florida, United States, 33308
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Fort Myers, Florida, United States, 33912
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Miami, Florida, United States, 33140
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Pompano Beach, Florida, United States, 33064
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St Petersburg, Florida, United States, 33716
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Sunrise, Florida, United States, 33351
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Tampa, Florida, United States, 33613
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Tampa Bay, Florida, United States, 33613
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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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Lexington, Kentucky, United States, 40503
United States, Louisiana
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Shreveport, Louisiana, United States, 71101
United States, Maryland
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Baltimore, Maryland, United States, 21224
United States, Massachusetts
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Boston, Massachusetts, United States, 02118
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Burlington, Massachusetts, United States, 01805
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West Yarmouth, Massachusetts, United States, 02673
United States, Missouri
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Kansas City, Missouri, United States, 64111
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St Louis, Missouri, United States, 63108
United States, New York
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Albany, New York, United States, 12208
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New York, New York, United States, 10032
United States, North Carolina
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Durham, North Carolina, United States, 27705
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Columbus, Ohio, United States, 43210
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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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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Jenkintown, Pennsylvania, United States, 19046
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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North Charleston, South Carolina, United States, 29406
United States, Utah
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Salt Lake City, Utah, United States, 84108
United States, Vermont
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Bennington, Vermont, United States, 05201
United States, Wisconsin
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Madison, Wisconsin, United States, 53705
Argentina
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Buenos Aires, Argentina, 1425
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Cordoba, Argentina, X5004AOA
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Santa Fe, Argentina, S3000FWO
Australia, New South Wales
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Hornsby, New South Wales, Australia, 2077
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Kogarah, New South Wales, Australia, 2217
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Randwick, Sydney, New South Wales, Australia, 2013
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Geelong, Victoria, Australia, 3220
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Heidelberg West, Victoria, Australia, 3081
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Kew, Victoria, Australia, 3101
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Belgium
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Aalst, Belgium, 9300
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Antwerp, Belgium, 2020
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Brugge, Belgium, 8000
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Leuven, Belgium, 3000
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y3G8
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Penticton, British Columbia, Canada, V2A5C8
Canada, Quebec
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Sherbrooke, Quebec, Canada, J1H1Z1
Canada
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Quebec, Canada, G1R 3X5
Chile
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Antofagasta, Chile
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Concepcion, Chile
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Santiago, Chile
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Santiago De Chile, Chile, 6640870
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Valdivia, Chile
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Vina Del Mar, Chile
Denmark
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Kobenhavn, Denmark, 2100
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Roskilde, Denmark, 4000
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Svendborg, 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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Nice, France, 06002
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Rennes, France, 35000
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Rouen, France, 76036
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Toulouse, France, 31059
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Tours, France, 37044
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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Chennai, India, 600003
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Hyderabaad, India, 400082
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Kolkatta, India, 700054
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Mangalore, India, 575002
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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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Fukuoka, Japan, 770-8076
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Kagawa, Japan, 761-0793
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Kochi, Japan, 780-0842
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Osaka, Japan, 590-0018
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Tokushima, Japan, 770-8076
Poland
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Bialystok, Poland, 15402
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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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Poznan, Poland, 61-606
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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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Johannesburg, South Africa, 1709
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Rosebank, South Africa, 2132
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Somerset West, South Africa, 7130
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Umhlanga, South Africa, 4319
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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Malmo, Sweden, 20502
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Molndal, Sweden, 43185
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Norrköping, Sweden, 60172
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Stockholm, Sweden, 14186
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Uddevalla, Sweden, 45180
United Kingdom
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Bath, Banes, United Kingdom, BA1 3NG
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Southampton, Hants, United Kingdom, SO30 3JB
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Liverpool, Merseyside, United Kingdom, L9 7LJ
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Glasgow, Scotland, United Kingdom, G20 0XA
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Swindon, Wilts, United Kingdom, SN1 4JU
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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
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):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00594568     History of Changes
Other Study ID Numbers: 7666, H6L-MC-LFAN, CTRI/2009/091/000090
Study First Received: January 11, 2008
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Chile: Ministry of Health
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 April 15, 2014