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

18 settembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Il morbo di Alzheimer

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1000

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

55 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Quadruplicare

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Comparatore placebo: Placebo	Droga: Placebo per via endovenosa (IV) ogni 4 settimane per 80 settimane
Sperimentale: LY2062430	Droga: LY2062430 400 mg per via endovenosa (IV) ogni 4 settimane per 80 settimane Altri nomi: Un anticorpo beta Solanezumab (*USAN nome adottato, INN in attesa)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Lasso di tempo
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks

Misure di risultato secondarie

Misura del risultato	Lasso di tempo
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite) Lasso di tempo: 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) Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) Lasso di tempo: 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. Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta Lasso di tempo: Baseline, 80 weeks	Baseline, 80 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2009

Completamento primario (Effettivo)

1 aprile 2012

Completamento dello studio (Effettivo)

1 aprile 2012

Date di iscrizione allo studio

Primo inviato

18 maggio 2009

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2009

Primo Inserito (Stima)

20 maggio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 settembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2012

Ultimo verificato

1 maggio 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

6747
H8A-MC-LZAM (Altro identificatore: Eli Lilly and Company)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su LY2062430

Eli Lilly and Company

Completato

Studio sulla sicurezza del solanezumab nei pazienti giapponesi con malattia di Alzheimer

Il morbo di Alzheimer

Giappone
Eli Lilly and Company

Completato

Effetti di LY2062430 in soggetti con malattia di Alzheimer da lieve a moderata e in volontari sani

Il morbo di Alzheimer

Stati Uniti
Eli Lilly and Company
Alzheimer's Therapeutic Research Institute

Completato

Sperimentazione clinica di Solanezumab per individui anziani che potrebbero essere a rischio di perdita di memoria (A4)

Disturbi cognitivi

Stati Uniti, Canada, Australia, Giappone
Eli Lilly and Company

Terminato

Uno studio su LY2599666 in partecipanti sani e partecipanti con lieve compromissione cognitiva o morbo di Alzheimer (AD)

Sano | Compromissione cognitiva lieve | Il morbo di Alzheimer

Stati Uniti, Giappone
Eli Lilly and Company

Terminato

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

Il morbo di Alzheimer

Stati Uniti, Argentina, Francia, Giappone, Canada, Corea, Repubblica di, Australia, Brasile, Spagna, Taiwan, Italia, Polonia, Germania, Federazione Russa, Regno Unito, Svezia
Eli Lilly and Company

Terminato

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)

Il morbo di Alzheimer

Italia, Stati Uniti, Spagna, Taiwan, Francia, Giappone, Porto Rico, Polonia, Svezia, Finlandia, Canada, Regno Unito, Germania
Eli Lilly and Company

Completato

Uno studio sui biomarcatori di Solanezumab in pazienti con e senza Alzheimer

Il morbo di Alzheimer

Stati Uniti
Eli Lilly and Company

Terminato

Progresso della malattia di Alzheimer lieve nei partecipanti a Solanezumab rispetto al placebo (EXPEDITION 3)

Il morbo di Alzheimer

Stati Uniti, Italia, Francia, Giappone, Australia, Germania, Spagna, Svezia, Canada, Polonia, Regno Unito
Eli Lilly and Company

Completato

Effetto di LY2062430 sulla progressione della malattia di Alzheimer (EXPEDITION2)

Il morbo di Alzheimer

Spagna, Stati Uniti, Francia, Corea, Repubblica di, Giappone, Australia, Taiwan, Svezia, Germania, Italia, Polonia, Federazione Russa, Regno Unito
Washington University School of Medicine
Eli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute... e altri collaboratori

Completato

Processo di rete di Alzheimer ereditato in modo dominante: un'opportunità per prevenire la demenza. Uno studio sui potenziali trattamenti che modificano la malattia in individui a rischio o con un tipo di malattia di Alzheimer ad esordio precoce causata da una mutazione genetica. (DIAN-TU)

Demenza | Il morbo di Alzheimer | Malattia di Alzheimer, familiare

Stati Uniti, Canada, Francia, Spagna, Irlanda, Australia, Porto Rico, Regno Unito

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

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Anticipato)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Lasso di tempo

Collaboratori e investigatori

Sponsor

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Prove cliniche su LY2062430

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Sweden

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi