A Study of Semagacestat for Alzheimer's Patients (Identity XT)
22 de septiembre de 2014 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
180
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Hannover, Alemania, 30559
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Muenchen, Alemania, 81675
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Regensburg, Alemania, D-93053
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Siegen, Alemania, 57072
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New South Wales
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Kogarah, New South Wales, Australia, 2217
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Victoria
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Geelong, Victoria, Australia, 3220
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Heidelberg West, Victoria, Australia, 3081
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y3G8
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Penticton, British Columbia, Canadá, V2A5C8
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Quebec
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Sherbrooke, Quebec, Canadá, J1H1Z1
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Antofagasta, Chile
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Santiago, Chile
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Valdivia, Chile
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Barcelona, España, 08003
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Plasencia, España, 10600
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
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Sun City, Arizona, Estados Unidos, 85351
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Tucson, Arizona, Estados Unidos, 85741
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California
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Costa Mesa, California, Estados Unidos, 92626
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Fresno, California, Estados Unidos, 93720
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Laguna Hills, California, Estados Unidos, 92653
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Lomita, California, Estados Unidos, 90717
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Orange, California, Estados Unidos, 92868
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San Diego, California, Estados Unidos, 92103
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San Francisco, California, Estados Unidos, 94109
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Santa Monica, California, Estados Unidos, 90404
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Connecticut
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Hamden, Connecticut, Estados Unidos, 06518
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New Haven, Connecticut, Estados Unidos, 06510
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20057
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Florida
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Brooksville, Florida, Estados Unidos, 34601
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Deerfield Beach, Florida, Estados Unidos, 33064
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Fort Lauderdale, Florida, Estados Unidos, 33308
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Fort Myers, Florida, Estados Unidos, 33912
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Hollywood, Florida, Estados Unidos, 33021
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Miami, Florida, Estados Unidos, 33137
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Orlando, Florida, Estados Unidos, 32806
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St Petersburg, Florida, Estados Unidos, 33716
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Tampa Bay, Florida, Estados Unidos, 33613
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70131
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Shreveport, Louisiana, Estados Unidos, 71104
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Massachusetts
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Hyannis, Massachusetts, Estados Unidos, 02601
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Missouri
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St Louis, Missouri, Estados Unidos, 63108
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New York
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New York, New York, Estados Unidos, 10032
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
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Raleigh, North Carolina, Estados Unidos, 27607
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Winston-Salem, North Carolina, Estados Unidos, 27103
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Ohio
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Toledo, Ohio, Estados Unidos, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73116
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
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Pennsylvania
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Jenkintown, Pennsylvania, Estados Unidos, 19046
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Philadelphia, Pennsylvania, Estados Unidos, 19104
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
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South Carolina
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North Charleston, South Carolina, Estados Unidos, 29406
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Vermont
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Bennington, Vermont, Estados Unidos, 05201
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Kuopio, Finlandia, 70210
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Oulu, Finlandia, 90229
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Toulouse, Francia, TSA 60033
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Ashkelon, Israel, 78306
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Petah Tikva, Israel, 49100
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Tel Hashomer, Israel, 52661
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Milano, Italia, 20132
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Fukui, Japón, 910-3113
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Fukuoka, Japón, 770-8076
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Kochi, Japón, 780-0842
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Tokushima, Japón, 770-0852
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Lublin, Polonia, 20-950
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Poznan, Polonia, 61- 485
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Bellville, Sudáfrica, 7530
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Stockholm, Suecia, 14186
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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.
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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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.
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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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
Periodo de tiempo: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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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
Periodo de tiempo: Baseline (LFAN Randomization), 24 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 24 weeks (LFBF)
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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.
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
Periodo de tiempo: Baseline (LFAN Randomization), 24 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 24 weeks (LFBF)
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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
Periodo de tiempo: Baseline (LFAN Randomization), 12 weeks (LFBF)
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2009
Finalización primaria (Actual)
1 de abril de 2011
Finalización del estudio (Actual)
1 de abril de 2011
Fechas de registro del estudio
Enviado por primera vez
17 de diciembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
17 de diciembre de 2009
Publicado por primera vez (Estimar)
18 de diciembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de septiembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
22 de septiembre de 2014
Última verificación
1 de septiembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5930
- H6L-MC-LFBF (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .