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Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)

18 września 2012 zaktualizowane przez: Eli Lilly and Company

Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo

Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

Przegląd badań

Status

Zakończony

Warunki

Choroba Alzheimera

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

1000

Faza

Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Argentyna
- - Buenos Aires, Argentyna, CBA 1419
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  - Cordoba, Argentyna, X5004AOA
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  - Mendoza, Argentyna, 5500
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  - Pueyrredon Cordoba, Argentyna, X5005ALB
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  - Rosario, Argentyna, S2000BZL
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  - Santa Fe, Argentyna, S3000FWO
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Brazylia
- - Curitiba, Brazylia, 81210-310
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  - Itapira, Brazylia, 13970-905
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  - Porto Alegre, Brazylia, 90110-270
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  - Rio De Janeiro, Brazylia, 20941-150
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  - São Paulo, Brazylia, 04024-002
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Japonia
- - Aichi, Japonia, 474-8511
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  - Fukuoka, Japonia, 812-0033
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  - Hiroshima, Japonia, 720-0825
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  - Kanagawa, Japonia, 243-8550
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  - Kyoto, Japonia, 607-8062
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  - Osaka, Japonia, 567
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  - Shizuoka, Japonia, 420-8688
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  - Tokyo, Japonia, 187-8551
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Kanada
- Alberta
  - Medicine Hat, Alberta, Kanada, T1B4E7
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- British Columbia
  - Kelowna, British Columbia, Kanada, V1Y3G8
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  - Penticton, British Columbia, Kanada, V2A5C8
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- Ontario
  - Ottawa, Ontario, Kanada, K1N 5C8
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  - Toronto, Ontario, Kanada, M6M 3Z5
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- Quebec
  - Greenfield Park, Quebec, Kanada, J4V 2J2
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  - Sherbrooke, Quebec, Kanada, J1H1Z1
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Stany Zjednoczone
- Arizona
  - Phoenix, Arizona, Stany Zjednoczone, 85006
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  - Sun City, Arizona, Stany Zjednoczone, 85351
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  - Tuscon, Arizona, Stany Zjednoczone, 85718
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- Arkansas
  - Little Rock, Arkansas, Stany Zjednoczone, 72205
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- California
  - Carson, California, Stany Zjednoczone, 90746
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  - Irvine, California, Stany Zjednoczone, 92697
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  - Laguna Hills, California, Stany Zjednoczone, 92653
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  - Lomita, California, Stany Zjednoczone, 90717
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  - Orange, California, Stany Zjednoczone, 92868
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  - Oxnard, California, Stany Zjednoczone, 93030
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  - Santa Ana, California, Stany Zjednoczone, 92705
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- Colorado
  - Denver, Colorado, Stany Zjednoczone, 80239
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- Connecticut
  - Fairfield, Connecticut, Stany Zjednoczone, 06824
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  - Hamden, Connecticut, Stany Zjednoczone, 06518
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  - New Haven, Connecticut, Stany Zjednoczone, 06510
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  - Norwalk, Connecticut, Stany Zjednoczone, 06851
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- Delaware
  - Newark, Delaware, Stany Zjednoczone, 19713
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- District of Columbia
  - Washington, District of Columbia, Stany Zjednoczone, 20007
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- Florida
  - Boca Raton, Florida, Stany Zjednoczone, 33431
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  - Fort Myers, Florida, Stany Zjednoczone, 33912
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  - Hollywood, Florida, Stany Zjednoczone, 33021
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  - Miami Springs, Florida, Stany Zjednoczone, 33166
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  - North Miami, Florida, Stany Zjednoczone, 33161
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  - Orange City, Florida, Stany Zjednoczone, 32763
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  - Orlando, Florida, Stany Zjednoczone, 32806
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  - Sunrise, Florida, Stany Zjednoczone, 33351
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  - Tampa, Florida, Stany Zjednoczone, 33613
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- Georgia
  - Atlanta, Georgia, Stany Zjednoczone, 30341
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  - Canton, Georgia, Stany Zjednoczone, 30114
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  - Decatur, Georgia, Stany Zjednoczone, 30033
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- Indiana
  - Indianapolis, Indiana, Stany Zjednoczone, 46202
    - 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.
- Kentucky
  - Lexington, Kentucky, Stany Zjednoczone, 40503
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- Maryland
  - Baltimore, Maryland, Stany Zjednoczone, 21285
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  - Rockville, Maryland, Stany Zjednoczone, 20852
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- Massachusetts
  - Belmont, Massachusetts, Stany Zjednoczone, 02478
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- Michigan
  - Grand Rapids, Michigan, Stany Zjednoczone, 49525
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  - Traverse City, Michigan, Stany Zjednoczone, 49684
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- New Mexico
  - Albuquerque, New Mexico, Stany Zjednoczone, 87109
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- New York
  - Albany, New York, Stany Zjednoczone, 12205
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  - Bronx, New York, Stany Zjednoczone, 10454
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  - Latham, New York, Stany Zjednoczone, 12210
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  - New York, New York, Stany Zjednoczone, 10032
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  - Orangeburg, New York, Stany Zjednoczone, 10962
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- North Carolina
  - Raleigh, North Carolina, Stany Zjednoczone, 27607
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  - Winston-Salem, North Carolina, Stany Zjednoczone, 27103
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- Ohio
  - Beachwood, Ohio, Stany Zjednoczone, 44122
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  - Toledo, Ohio, Stany Zjednoczone, 43623
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- Oklahoma
  - Oklahoma City, Oklahoma, Stany Zjednoczone, 73116
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- Oregon
  - Eugene, Oregon, Stany Zjednoczone, 97401
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- Pennsylvania
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
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- Rhode Island
  - East Providence, Rhode Island, Stany Zjednoczone, 02914
    - 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.
- South Carolina
  - Charleston, South Carolina, Stany Zjednoczone, 29425
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  - Greer, South Carolina, Stany Zjednoczone, 29651
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- South Dakota
  - Sioux Falls, South Dakota, Stany Zjednoczone, 57105
    - 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.
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone, 84108
    - 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.
- Vermont
  - Bennington, Vermont, Stany Zjednoczone, 05201
    - 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.
  - Burlington, Vermont, Stany Zjednoczone, 05401
    - 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.
- Virginia
  - Norfolk, Virginia, Stany Zjednoczone, 23502
    - 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.
  - Roanoke, Virginia, Stany Zjednoczone, 24018
    - 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.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

55 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization

Exclusion Criteria:

Has serious or unstable illness(es)
Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
Has allergies to humanized monoclonal antibodies
Chronic alcohol and/or drug abuse within the past 5 years
Has any contraindications for MRI studies
Requires treatment with another monoclonal antibody

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Poczwórny

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Komparator placebo: Placebo	Lek: Placebo dożylnie (IV) co 4 tygodnie przez 80 tygodni
Eksperymentalny: LY2062430	Lek: LY2062430 400 mg dożylnie (IV) co 4 tygodnie przez 80 tygodni Inne nazwy: Przeciwciało Beta Solanezumab (*nazwa przyjęta przez USAN, INN w toku)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Ramy czasowe
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks

Miary wyników drugorzędnych

Miara wyniku	Ramy czasowe
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels. Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta Ramy czasowe: Baseline, 80 weeks	Baseline, 80 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2009

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2012

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2012

Daty rejestracji na studia

Pierwszy przesłany

18 maja 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2009

Pierwszy wysłany (Oszacować)

20 maja 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

25 września 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 września 2012

Ostatnia weryfikacja

1 maja 2012

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

6747
H8A-MC-LZAM (Inny identyfikator: Eli Lilly and Company)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Przegląd badań

Status

Warunki

Interwencja / Leczenie

Typ studiów

Zapisy (Oczekiwany)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Ramy czasowe

Współpracownicy i badacze

Sponsor

Publikacje i pomocne linki

Publikacje ogólne

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Rzeczywisty)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Oszacować)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Badania kliniczne na Choroba Alzheimera

Badania kliniczne na LY2062430

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Suplementy diety

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