Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
March 13, 2015 updated by: Eli Lilly and Company
Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo
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 (β-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 (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-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 β-amyloid and amyloid plaques for some participants. 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 participants. In this trial, participants 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 participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.
Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study (H6L-MC-LFBC [LFBC; NCT00762411]) 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. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1537
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1425
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Cordoba, Argentina, X5004AOA
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Santa Fe, Argentina, S3000FWO
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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
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South Australia
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Adelaide, South Australia, Australia, 5000
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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
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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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
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Quebec, Canada, G1R 3X5
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British Columbia
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Kelowna, British Columbia, Canada, V1Y3G8
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Penticton, British Columbia, Canada, V2A5C8
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Quebec
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Sherbrooke, Quebec, Canada, J1H1Z1
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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
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Kobenhavn, Denmark, 2100
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Roskilde, Denmark, 4000
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Svendborg, Denmark, 4000
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Kuopio, Finland, 70210
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Mikkeli, Finland, 50100
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Oulu, Finland, 90229
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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
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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
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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
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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
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Milano, Italy, 20157
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Pisa, Italy, 56126
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Rome, Italy, 00153
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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
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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
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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
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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
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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
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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
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Banes
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Bath, Banes, United Kingdom, BA1 3NG
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Hants
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Southampton, Hants, United Kingdom, SO30 3JB
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Merseyside
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Liverpool, Merseyside, United Kingdom, L9 7LJ
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Scotland
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Glasgow, Scotland, United Kingdom, G20 0XA
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Wilts
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Swindon, Wilts, United Kingdom, SN1 4JU
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Alabama
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Birmingham, Alabama, United States, 35294
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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
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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
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Connecticut
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Hamden, Connecticut, United States, 06518
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New Haven, Connecticut, United States, 06510
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District of Columbia
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Washington, District of Columbia, United States, 20057
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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
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Illinois
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Chicago, Illinois, United States, 60611
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Indiana
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Indianapolis, Indiana, United States, 46202
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Kentucky
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Lexington, Kentucky, United States, 40503
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Louisiana
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Shreveport, Louisiana, United States, 71101
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Maryland
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Baltimore, Maryland, United States, 21224
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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
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Missouri
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Kansas City, Missouri, United States, 64111
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St Louis, Missouri, United States, 63108
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New York
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Albany, New York, United States, 12208
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New York, New York, United States, 10032
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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
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Ohio
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Columbus, Ohio, United States, 43210
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Toledo, Ohio, United States, 43623
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
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Oregon
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Eugene, Oregon, United States, 97401
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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
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Rhode Island
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East Providence, Rhode Island, United States, 02914
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South Carolina
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North Charleston, South Carolina, United States, 29406
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Utah
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Salt Lake City, Utah, United States, 84108
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Vermont
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Bennington, Vermont, United States, 05201
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 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 AD
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Participants received placebo orally once daily for the first 76 weeks.
At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
|
Administered orally once daily
|
|
Experimental: 100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
|
Administered orally once daily
Other Names:
|
|
Experimental: 140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
|
Administered orally once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
ADAS-Cog11 was used as a primary efficacy measure.
It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis.
The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 16 weeks following treatment cessation
|
ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis.
The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 16 weeks following treatment cessation
|
|
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver.
It measures performance of basic and instrumental activities of daily living by participants.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 16 weeks following treatment cessation
|
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver.
It measures performance of basic and instrumental activities of daily living by participants.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 16 weeks following treatment cessation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG.
The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Time Frame: Baseline (randomization), up to 76 weeks
|
Concentration of total tau in spinal fluid.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (randomization), up to 76 weeks
|
|
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks
Time Frame: Baseline (randomization), 52 weeks
|
Concentration of amino acid peptide, known as Aβ 1-42, in plasma.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (randomization), 52 weeks
|
|
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
Time Frame: Baseline (randomization), up to 76 weeks
|
The vMRI assessment of left and right hippocampal volume is reported.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (randomization), up to 76 weeks
|
|
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
Time Frame: Baseline (randomization), up to 76 weeks
|
A radioactive tracer for PET that is a ligand for amyloid called AV-45.
This permits the visualization of amyloid in the brains of Alzheimer's participants.
The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (randomization), up to 76 weeks
|
|
LY450139 Population Pharmacokinetics: Clearance of LY450139
Time Frame: 6 weeks, 12 weeks, and 52 weeks
|
Model estimated apparent oral clearance.
Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.
|
6 weeks, 12 weeks, and 52 weeks
|
|
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Time Frame: 6 weeks, 12 weeks, and 52 weeks
|
Model-estimated apparent volume of distribution.
Volume of distribution is a measure of the extent to which the drug distributes in the body.
|
6 weeks, 12 weeks, and 52 weeks
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures.
A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90.
Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants.
The total score ranges from 0 to 30; Lower score indicates greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
|
Baseline (randomization), 76 weeks
|
|
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
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Baseline (randomization), 76 weeks
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Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
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NPI assesses psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the participant's behavior.
Total score ranges from 12 to 144; Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
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Baseline (randomization), 76 weeks
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Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks
Time Frame: Baseline (randomization), 76 weeks
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EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3).
Digits are combined into 5-digit number describing health state.
Numerals 1-3 are not added for total score.
VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity.
Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
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Baseline (randomization), 76 weeks
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Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks
Time Frame: Baseline (randomization), up to 76 weeks
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Assesses healthcare resource utilization (formal and informal care).
Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks.
Least Squares (LS) Mean value was controlled for age and investigator.
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Baseline (randomization), up to 76 weeks
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 16 weeks following treatment cessation
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ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
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Baseline (randomization), 16 weeks following treatment cessation
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 16 weeks following treatment cessation
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ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures.
A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90.
Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
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Baseline (randomization), 16 weeks following treatment cessation
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Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 4 weeks following treatment cessation
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Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care.
Severity score assigned for each of 6 domains.
Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity.
LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening.
Participants followed off-dose for 32 weeks, but CDR-SB not assessed.
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Baseline (randomization), 4 weeks following treatment cessation
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Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 4 weeks following treatment cessation
|
NPI assesses psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with participant's behavior.
Total score ranges from 12 to 144; Higher scores indicate greater disease severity.
Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening.
Participants were followed off-dose for 32 weeks, but NPI was not assessed
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Baseline (randomization), 4 weeks following treatment cessation
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Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 4 weeks following treatment cessation
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MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants.
Total score ranges from 0 to 30; Lower score indicates greater disease severity.
LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening.
Participants were followed off-dose for 32 weeks, but MMSE was not assessed.
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Baseline (randomization), 4 weeks following treatment cessation
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Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 4 weeks following treatment cessation
|
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
3 severity levels: no, some, severe problems.
VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity.
LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening.
Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.
|
Baseline (randomization), 4 weeks following treatment cessation
|
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Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug
Time Frame: Baseline (randomization), 4 weeks following treatment cessation
|
RUD-Lite assesses healthcare resource utilization (formal and informal care).
Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected.
Reported number of participant hospitalizations.
Least Squares (LS) Mean value controlled for age and investigator.
All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening.
Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.
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Baseline (randomization), 4 weeks following treatment cessation
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Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Time Frame: Baseline (randomization), up to 76 weeks
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Concentration of an amino peptide known as Aβ 1-42 in spinal fluid.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
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Baseline (randomization), up to 76 weeks
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Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid
Time Frame: Baseline (randomization), up to 76 weeks
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Concentration of p-tau in spinal fluid.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
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Baseline (randomization), up to 76 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.
- Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.
- Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of gamma-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015.
- Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee; Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 13, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7666
- H6L-MC-LFAN (Other Identifier: Eli Lilly and Company)
- CTRI/2009/091/000090 (Registry Identifier: India)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.