Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-12-31
Study Completion Date
2011-04-30
Brief Summary
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The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).
Preliminary results from LFAN and 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. Studies LFAN, LFBC and 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. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.
Preliminary results from LFAN and 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. Studies LFAN, LFBC and 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. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.
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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
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Drug: semagacestat
Group Type
EXPERIMENTAL
semagacestat
Intervention Type
DRUG
140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Interventions
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semagacestat
140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Intervention Type
DRUG
Other Intervention Names
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LY450139
Eligibility Criteria
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Inclusion Criteria
* Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
* Completed semagacestat study LFAN or study LFBC through 88 weeks
* Must continue to have a reliable caregiver
* Capable of swallowing whole oral medication
* Agrees not to participate in other investigational compounds for the duration of study
* Completed semagacestat study LFAN or study LFBC through 88 weeks
* Must continue to have a reliable caregiver
* Capable of swallowing whole oral medication
* Agrees not to participate in other investigational compounds for the duration of study
Exclusion Criteria
* Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
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
Locations
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Costa Mesa, California, United States
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Fresno, California, United States
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Laguna Hills, California, United States
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Lomita, California, United States
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Orange, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Hamden, Connecticut, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Brooksville, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tampa Bay, Florida, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Hyannis, Massachusetts, United States
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St Louis, Missouri, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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East Providence, Rhode Island, United States
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North Charleston, South Carolina, United States
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Bennington, Vermont, United States
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Kogarah, New South Wales, Australia
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Geelong, Victoria, Australia
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Heidelberg West, Victoria, Australia
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Kelowna, British Columbia, Canada
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Penticton, British Columbia, Canada
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Sherbrooke, Quebec, Canada
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Antofagasta, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Kuopio, , Finland
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Oulu, , Finland
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Toulouse, , France
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Hanover, , Germany
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München, , Germany
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Regensburg, , Germany
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Siegen, , Germany
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Ashkelon, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Milan, , Italy
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Fukui, , Japan
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Fukuoka, , Japan
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Kochi, , Japan
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Tokushima, , Japan
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Lublin, , Poland
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Poznan, , Poland
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Bellville, , South Africa
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Barcelona, , Spain
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Plasencia, , Spain
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Stockholm, , Sweden
Site Status
Countries
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United States
Australia
Canada
Chile
Finland
France
Germany
Israel
Italy
Japan
Poland
South Africa
Spain
Sweden
Other Identifiers
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H6L-MC-LFBF
Identifier Type: OTHER
Identifier Source: secondary_id
5930
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
NCT03518073
COMPLETED
PHASE2
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
NCT01369225
COMPLETED
PHASE1
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
NCT03363269
COMPLETED
PHASE2
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
NCT00006187
TERMINATED
PHASE3
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
NCT05225415
COMPLETED
PHASE2
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
NCT01421056
COMPLETED
PHASE2
Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease
NCT00551161
COMPLETED
PHASE4
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
NCT04374136
ACTIVE_NOT_RECRUITING
PHASE3
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
NCT02991235
UNKNOWN
NA
A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease
NCT01807026
COMPLETED
PHASE1