Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo
NCT ID: NCT00762411
Last Updated: 2015-02-16
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1111 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-09-30
Study Completion Date
2011-04-30
Brief Summary
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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 patients. The buildup 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 2 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 this study (LFBC) (and another similar study LFAN \[NCT00594568\]) 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. LFBC, LFAN and open label LFBF (NCT01035138) 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.
Preliminary results from this study (LFBC) (and another similar study LFAN \[NCT00594568\]) 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. LFBC, LFAN and open label LFBF (NCT01035138) 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.
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Detailed Description
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Conditions
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Alzheimer's Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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LY450139
Participants received 60 milligrams (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.
Group Type
EXPERIMENTAL
LY450139
Intervention Type
DRUG
Administered orally once daily.
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered orally once daily.
Interventions
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LY450139
Administered orally once daily.
Intervention Type
DRUG
Placebo
Administered orally once daily.
Intervention Type
DRUG
Other Intervention Names
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Semagacestat
Eligibility Criteria
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Inclusion Criteria
* Meets criteria for mild to moderate Alzheimer's disease (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 AD
* If female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed.
* 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 a 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 and/or drug abuse within the past 5 years
* Has ever had a active vaccination for AD
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol and/or drug abuse within the past 5 years
* Has ever had a active vaccination for AD
Minimum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
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Kragujevac, , Serbia
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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Changhua, , Taiwan
Site Status
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Tainan City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Taoyuan District, , Taiwan
Site Status
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Eskişehir, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Izmir, , Turkey (Türkiye)
Site Status
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Samsun, , Turkey (Türkiye)
Site Status
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Dnipropetrovsk, , Ukraine
Site Status
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Donetsk, , Ukraine
Site Status
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Kherson, , Ukraine
Site Status
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Kyiv, , Ukraine
Site Status
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Odesa, , Ukraine
Site Status
Countries
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United States
Brazil
Bulgaria
Canada
China
France
Germany
Hungary
Italy
Japan
Mexico
Romania
Russia
Serbia
South Korea
Taiwan
Turkey (Türkiye)
Ukraine
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H6L-MC-LFBC
Identifier Type: OTHER
Identifier Source: secondary_id
11271
Identifier Type: -
Identifier Source: org_study_id
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