A Study of Semagacestat for Alzheimer's Patients (Identity XT)
22 сентября 2014 г. обновлено: Eli Lilly and Company
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.
Обзор исследования
Тип исследования
Интервенционный
Регистрация (Действительный)
180
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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New South Wales
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Kogarah, New South Wales, Австралия, 2217
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Victoria
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Geelong, Victoria, Австралия, 3220
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Heidelberg West, Victoria, Австралия, 3081
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Hannover, Германия, 30559
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Muenchen, Германия, 81675
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Regensburg, Германия, D-93053
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Siegen, Германия, 57072
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Ashkelon, Израиль, 78306
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Petah Tikva, Израиль, 49100
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Tel Hashomer, Израиль, 52661
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Barcelona, Испания, 08003
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Plasencia, Испания, 10600
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Milano, Италия, 20132
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British Columbia
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Kelowna, British Columbia, Канада, V1Y3G8
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Penticton, British Columbia, Канада, V2A5C8
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Quebec
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Sherbrooke, Quebec, Канада, J1H1Z1
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Lublin, Польша, 20-950
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Poznan, Польша, 61- 485
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85004
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Sun City, Arizona, Соединенные Штаты, 85351
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Tucson, Arizona, Соединенные Штаты, 85741
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California
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Costa Mesa, California, Соединенные Штаты, 92626
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Fresno, California, Соединенные Штаты, 93720
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Laguna Hills, California, Соединенные Штаты, 92653
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Lomita, California, Соединенные Штаты, 90717
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Orange, California, Соединенные Штаты, 92868
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San Diego, California, Соединенные Штаты, 92103
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San Francisco, California, Соединенные Штаты, 94109
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Santa Monica, California, Соединенные Штаты, 90404
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Connecticut
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Hamden, Connecticut, Соединенные Штаты, 06518
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New Haven, Connecticut, Соединенные Штаты, 06510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20057
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Brooksville, Florida, Соединенные Штаты, 34601
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Deerfield Beach, Florida, Соединенные Штаты, 33064
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Fort Lauderdale, Florida, Соединенные Штаты, 33308
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Fort Myers, Florida, Соединенные Штаты, 33912
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Hollywood, Florida, Соединенные Штаты, 33021
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Miami, Florida, Соединенные Штаты, 33137
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Orlando, Florida, Соединенные Штаты, 32806
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St Petersburg, Florida, Соединенные Штаты, 33716
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Tampa Bay, Florida, Соединенные Штаты, 33613
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
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Kentucky
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Lexington, Kentucky, Соединенные Штаты, 40503
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Louisiana
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New Orleans, Louisiana, Соединенные Штаты, 70131
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Shreveport, Louisiana, Соединенные Штаты, 71104
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Massachusetts
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Hyannis, Massachusetts, Соединенные Штаты, 02601
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63108
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New York
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New York, New York, Соединенные Штаты, 10032
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North Carolina
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Durham, North Carolina, Соединенные Штаты, 27705
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Raleigh, North Carolina, Соединенные Штаты, 27607
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
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Ohio
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Toledo, Ohio, Соединенные Штаты, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73116
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Oregon
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Eugene, Oregon, Соединенные Штаты, 97401
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Pennsylvania
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Jenkintown, Pennsylvania, Соединенные Штаты, 19046
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
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Rhode Island
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East Providence, Rhode Island, Соединенные Штаты, 02914
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South Carolina
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North Charleston, South Carolina, Соединенные Штаты, 29406
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Vermont
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Bennington, Vermont, Соединенные Штаты, 05201
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Kuopio, Финляндия, 70210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oulu, Финляндия, 90229
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Toulouse, Франция, TSA 60033
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Antofagasta, Чили
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santiago, Чили
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valdivia, Чили
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stockholm, Швеция, 14186
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Bellville, Южная Африка, 7530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukui, Япония, 910-3113
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Япония, 770-8076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kochi, Япония, 780-0842
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokushima, Япония, 770-0852
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
55 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Exclusion Criteria:
- Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Drug: semagacestat
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140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug
Временное ограничение: Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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The cognitive subscale of the ADAS (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.
|
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
|
|
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug
Временное ограничение: Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
|
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver.
It measures both basic and instrumental activities of daily living.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
|
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12
Временное ограничение: Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
|
Concentration of amino acid peptide known as Aβ 1-42 in plasma.
Least Square (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
|
|
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
The vMRI assessment of right hippocampal and left hippocampal volume is reported.
Least Square (LS) Mean value was controlled for baseline value, age, and investigator.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
A radioactive tracer for PET that is a ligand for amyloid called [18F]-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 for the cerebellar gray matter.
Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Due to insufficient sample size, this analysis was not done.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
The cognitive subscale of the ADAS (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 Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.
Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
The ADAS-Cog14 is the 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 Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver.
It measures both basic and instrumental activities of daily living.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
|
Mean Concentration of LY450139
Временное ограничение: 3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
|
3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
|
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug
Временное ограничение: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
|
ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.
|
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug
Временное ограничение: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
|
The ADAS-Cog14 is the 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.
|
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
|
|
Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24
Временное ограничение: Baseline (LFAN Randomization), 24 weeks (LFBF)
|
The CDR-SB is a semi-structured interview of participants and their caregivers.
The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity.
Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 24 weeks (LFBF)
|
|
Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24
Временное ограничение: Baseline (LFAN Randomization), 24 weeks (LFBF)
|
The MMSE is a brief screening instrument used to assess cognitive function in elderly participants.
It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures.
The total score ranges from 0 to 30, with a lower score indicating greater disease severity.
Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 24 weeks (LFBF)
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
Временное ограничение: Baseline (LFAN Randomization), 24 weeks (LFBF)
|
The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the patient's behavior.
The score ranges from 12 to 144, with higher scores indicating greater disease severity.
Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.
|
Baseline (LFAN Randomization), 24 weeks (LFBF)
|
|
Change From Baseline in EuroQol-5D (EQ-5D) at Week 24
Временное ограничение: Baseline (LFAN Randomization), 24 weeks (LFBF)
|
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.
Numbers 1-3 are not added for total score.
Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity.
LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
|
Baseline (LFAN Randomization), 24 weeks (LFBF)
|
|
Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12
Временное ограничение: Baseline (LFAN Randomization), 12 weeks (LFBF)
|
RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD).
Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.
Reported the change in number of hospitalizations per participant to week 12.
|
Baseline (LFAN Randomization), 12 weeks (LFBF)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 декабря 2009 г.
Первичное завершение (Действительный)
1 апреля 2011 г.
Завершение исследования (Действительный)
1 апреля 2011 г.
Даты регистрации исследования
Первый отправленный
17 декабря 2009 г.
Впервые представлено, что соответствует критериям контроля качества
17 декабря 2009 г.
Первый опубликованный (Оценивать)
18 декабря 2009 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
25 сентября 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 сентября 2014 г.
Последняя проверка
1 сентября 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 5930
- H6L-MC-LFBF (Другой идентификатор: Eli Lilly and Company)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .