Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)
Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)
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.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85004, United States
Sun City, Arizona 85351, United States
Tucson, Arizona 85741, United States
Costa Mesa, California 92626, United States
Fresno, California 93720, United States
Laguna Hills, California 92653, United States
Lomita, California 90717, United States
Orange, California 92868, United States
San Diego, California 92103, United States
San Francisco, California 94109, United States
Santa Monica, California 90404, United States
Hamden, Connecticut 06518, United States
New Haven, Connecticut 06510, United States
Washington D.C., District of Columbia 20057, United States
Brooksville, Florida 34601, United States
Deerfield Beach, Florida 33064, United States
Fort Lauderdale, Florida 33308, United States
Fort Myers, Florida 33912, United States
Hollywood, Florida 33021, United States
Miami, Florida 33137, United States
Orlando, Florida 32806, United States
St. Petersburg, Florida 33716, United States
Tampa Bay, Florida 33613, United States
Indianapolis, Indiana 46202, United States
Lexington, Kentucky 40503, United States
New Orleans, Louisiana 70131, United States
Shreveport, Louisiana 71104, United States
Hyannis, Massachusetts 02601, United States
St Louis, Missouri 63108, United States
New York, New York 10032, United States
Durham, North Carolina 27705, United States
Raleigh, North Carolina 27607, United States
Winston-Salem, North Carolina 27103, United States
Toledo, Ohio 43623, United States
Oklahoma City, Oklahoma 73116, United States
Eugene, Oregon 97401, United States
Jenkintown, Pennsylvania 19046, United States
Philadelphia, Pennsylvania 19104, United States
East Providence, Rhode Island 02914, United States
North Charleston, South Carolina 29406, United States
Bennington, Vermont 05201, United States
Kogarah, New South Wales 2217, Australia
Geelong, Victoria 3220, Australia
Heidelberg West, Victoria 3081, Australia
Kelowna, British Columbia V1Y3G8, Canada
Penticton, British Columbia V2A5C8, Canada
Sherbrooke, Quebec J1H1Z1, Canada
Antofagasta, Chile
Santiago, Chile
Valdivia, Chile
Kuopio, 70210, Finland
Oulu, 90229, Finland
Toulouse, TSA 60033, France
Hanover, 30559, Germany
München, 81675, Germany
Regensburg, D-93053, Germany
Siegen, 57072, Germany
Ashkelon, 78306, Israel
Petah Tikva, 49100, Israel
Tel Litwinsky, 52661, Israel
Milan, 20132, Italy
Fukui, 910-3113, Japan
Fukuoka, 770-8076, Japan
Kochi, 780-0842, Japan
Tokushima, 770-0852, Japan
Lublin, 20-950, Poland
Poznan, 61- 485, Poland
Bellville, 7530, South Africa
Barcelona, 08003, Spain
Plasencia, 10600, Spain