A Study of Semagacestat for Alzheimer's Patients (Identity XT)
22. září 2014 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
180
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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New South Wales
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Kogarah, New South Wales, Austrálie, 2217
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Victoria
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Geelong, Victoria, Austrálie, 3220
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Heidelberg West, Victoria, Austrálie, 3081
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Antofagasta, Chile
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Santiago, Chile
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Valdivia, Chile
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Kuopio, Finsko, 70210
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Oulu, Finsko, 90229
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Toulouse, Francie, TSA 60033
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Milano, Itálie, 20132
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Ashkelon, Izrael, 78306
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Petah Tikva, Izrael, 49100
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Tel Hashomer, Izrael, 52661
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Fukui, Japonsko, 910-3113
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Fukuoka, Japonsko, 770-8076
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Kochi, Japonsko, 780-0842
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Tokushima, Japonsko, 770-0852
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Bellville, Jižní Afrika, 7530
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y3G8
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Penticton, British Columbia, Kanada, V2A5C8
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Quebec
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Sherbrooke, Quebec, Kanada, J1H1Z1
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Hannover, Německo, 30559
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Muenchen, Německo, 81675
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Regensburg, Německo, D-93053
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Siegen, Německo, 57072
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Lublin, Polsko, 20-950
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Poznan, Polsko, 61- 485
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Arizona
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Phoenix, Arizona, Spojené státy, 85004
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Sun City, Arizona, Spojené státy, 85351
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Tucson, Arizona, Spojené státy, 85741
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California
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Costa Mesa, California, Spojené státy, 92626
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Fresno, California, Spojené státy, 93720
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Laguna Hills, California, Spojené státy, 92653
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Lomita, California, Spojené státy, 90717
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Orange, California, Spojené státy, 92868
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San Diego, California, Spojené státy, 92103
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San Francisco, California, Spojené státy, 94109
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Santa Monica, California, Spojené státy, 90404
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Connecticut
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Hamden, Connecticut, Spojené státy, 06518
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New Haven, Connecticut, Spojené státy, 06510
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20057
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Florida
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Brooksville, Florida, Spojené státy, 34601
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Deerfield Beach, Florida, Spojené státy, 33064
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Fort Lauderdale, Florida, Spojené státy, 33308
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Fort Myers, Florida, Spojené státy, 33912
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Hollywood, Florida, Spojené státy, 33021
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Miami, Florida, Spojené státy, 33137
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Orlando, Florida, Spojené státy, 32806
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St Petersburg, Florida, Spojené státy, 33716
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Tampa Bay, Florida, Spojené státy, 33613
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
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Kentucky
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Lexington, Kentucky, Spojené státy, 40503
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70131
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Shreveport, Louisiana, Spojené státy, 71104
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Massachusetts
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Hyannis, Massachusetts, Spojené státy, 02601
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Missouri
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St Louis, Missouri, Spojené státy, 63108
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New York
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New York, New York, Spojené státy, 10032
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North Carolina
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Durham, North Carolina, Spojené státy, 27705
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Raleigh, North Carolina, Spojené státy, 27607
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Winston-Salem, North Carolina, Spojené státy, 27103
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Ohio
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Toledo, Ohio, Spojené státy, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73116
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Oregon
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Eugene, Oregon, Spojené státy, 97401
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Pennsylvania
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Jenkintown, Pennsylvania, Spojené státy, 19046
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Philadelphia, Pennsylvania, Spojené státy, 19104
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Rhode Island
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East Providence, Rhode Island, Spojené státy, 02914
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South Carolina
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North Charleston, South Carolina, Spojené státy, 29406
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Vermont
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Bennington, Vermont, Spojené státy, 05201
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Barcelona, Španělsko, 08003
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Plasencia, Španělsko, 10600
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Stockholm, Švédsko, 14186
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
55 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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.
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Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug
Časové okno: Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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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.
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Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12
Časové okno: Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
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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.
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Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
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Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
Časové okno: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Mean Concentration of LY450139
Časové okno: 3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
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3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug
Časové okno: 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.
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Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug
Časové okno: 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.
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Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24
Časové okno: 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.
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24
Časové okno: 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)
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Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
Časové okno: 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.
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Change From Baseline in EuroQol-5D (EQ-5D) at Week 24
Časové okno: 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.
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12
Časové okno: 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.
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2009
Primární dokončení (Aktuální)
1. dubna 2011
Dokončení studie (Aktuální)
1. dubna 2011
Termíny zápisu do studia
První předloženo
17. prosince 2009
První předloženo, které splnilo kritéria kontroly kvality
17. prosince 2009
První zveřejněno (Odhad)
18. prosince 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
25. září 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. září 2014
Naposledy ověřeno
1. září 2014
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 5930
- H6L-MC-LFBF (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .