A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
keskiviikko 25. syyskuuta 2019 päivittänyt: Eli Lilly and Company
A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
26
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Barcelona, Espanja, 08025
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Barcelona, Espanja, 08036
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Barcelona, Espanja, 08014
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Castellon de la Plana, Espanja, 12004
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Getafe, Espanja, 28905
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Getxo, Espanja, 48993
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Madrid, Espanja, 28006
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Plasencia, Espanja, 10600
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Salt, Espanja, 17190
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San Sebastian, Espanja, 20009
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Valencia, Espanja, 46017
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Valencia, Espanja, 46026
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Genova, Italia, 16132
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Milano, Italia, 20122
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Milano, Italia, 20133
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Monza, Italia, 20052
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Pavia, Italia, 27100
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Perugia, Italia, 06134
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Pisa, Italia, 56126
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Roma, Italia, 00161
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Roma, Italia, 00153
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Roma, Italia, 00179
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Roma, Italia, 00189
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Bunkyo-ku, Japani, 113-8655
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Bunkyo-ku, Japani, 113-8431
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Hachioji, Japani, 193-0998
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Hyogo, Japani, 673-0848
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Kamakura, Japani, 247-8533
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Kodaira-shi, Japani, 187-8551
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Koriyama, Japani, 963-8052
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Kyoto-shi, Japani, 607-8113
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Mitaka-shi, Japani, 181-0013
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Shinjuku-Ku, Japani, 160-8582
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Shizuoka, Japani, 424-0911
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Takamatsu, Japani, 760-8557
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Tokyo, Japani, 113-0034
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Tsu-shi, Japani, 514-8507
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Gatineau, Kanada, J8T 8J1
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Greenfield Park, Kanada, J4V 2J2
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Halifax, Kanada, B3S1M7
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Kentville, Kanada, B4N 4K9
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London, Kanada, N6C 0A7
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Ottawa, Kanada, KIN 5C8
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Peterborough, Kanada, K9H2P4
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Sherbrooke, Kanada, J1H1Z1
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Toronto, Kanada, M3B 2S7
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Bayamón, Puerto Rico, 00961-6911
- Santa Cruz Behavioral PSC
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Las Piedras, Puerto Rico, 00771
- Cortex, PSC
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Rio Piedras, Puerto Rico, 00936
- University of Puerto Rico
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San Juan, Puerto Rico, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, Puerto Rico, 00918
- SomniCare Sleep Institute
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San Juan, Puerto Rico, 00918
- Latin Clinical Trial Center
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Białystok, Puola, 15-732
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Bydgoszcz, Puola, 85-796
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Lublin, Puola, 20-093
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Poznan, Puola, 30-856
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Sopot, Puola, 81-824
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Warszawa, Puola, 01-697
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Amiens, Ranska, 80054
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Bordeaux, Ranska, 33076
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Bron, Ranska, 69677
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Lille, Ranska, 59037
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Marseille, Ranska, 13385
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Montpellier, Ranska, 34295
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Paris, Ranska, 75015
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Paris, Ranska, 75651
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Paris, Ranska, 75010
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Rennes, Ranska, 35033
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Strasbourg, Ranska, 67000
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Toulouse, Ranska, 31059
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Malmö, Ruotsi, 20502
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Mölndal, Ruotsi, 43141
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Stockholm, Ruotsi, 113 61
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Umeå, Ruotsi, 90105
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Chemnitz, Saksa, 09131
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Kuopio, Suomi, 70210
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Oulu, Suomi, 90100
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Tampere, Suomi, 33100
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Turku, Suomi, 20014
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Vaasa, Suomi, 65130
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Changhua, Taiwan, 500
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Gwei Shan Township, Taiwan, 333
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Jhonghe City, Taiwan, 235
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Kaohsiung, Taiwan, 80756
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Kaohsiung, Taiwan, 83301
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10048
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Taipei, Taiwan, 11217
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Bath, Yhdistynyt kuningaskunta, BA1 3NG
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Chelsea, Yhdistynyt kuningaskunta, W6 8RF
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Guildford, Yhdistynyt kuningaskunta, GU2 7YD
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London, Yhdistynyt kuningaskunta, W1G 9RU
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Manchester, Yhdistynyt kuningaskunta, M13 9WL
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Scotland, Yhdistynyt kuningaskunta, G20 0XA
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Yhdysvallat, 85013
- St Josephs Hospital and Medical Center
-
Phoenix, Arizona, Yhdysvallat, 85004
- Xenoscience
-
Sun City, Arizona, Yhdysvallat, 85351
- Banner Sun Health Research Institute
-
Tucson, Arizona, Yhdysvallat, 85718
- Center for Neurosciences
-
Tucson, Arizona, Yhdysvallat, 85724
- Arizona Health Sciences Center
-
-
California
-
Glendale, California, Yhdysvallat, 91206-4140
- Parexel Early Phase Unit at Glendale
-
Oxnard, California, Yhdysvallat, 93030
- Pacific Neuroscience Medical Group
-
Rancho Mirage, California, Yhdysvallat, 92270
- Desert Valley Research
-
San Diego, California, Yhdysvallat, 92123
- Sharp Mesa Vista Hospital
-
San Diego, California, Yhdysvallat, 92103
- Pacific Research Network Inc
-
San Francisco, California, Yhdysvallat, 94114
- California Pacific Medical Center
-
Santa Ana, California, Yhdysvallat, 92705
- Apex Research Institute
-
Santa Clarita, California, Yhdysvallat, 91321
- Care Access Research LLC
-
Sherman Oaks, California, Yhdysvallat, 91403
- California Neuroscience Research
-
Valencia, California, Yhdysvallat, 91355
- Care Access Research
-
-
Colorado
-
Colorado Springs, Colorado, Yhdysvallat, 80910
- MCB Clinical Research Centers
-
Denver, Colorado, Yhdysvallat, 80218
- Mile High Research Center
-
-
Connecticut
-
New Haven, Connecticut, Yhdysvallat, 06510
- Yale University School of Medicine
-
Stamford, Connecticut, Yhdysvallat, 06905
- New England Institute for Clinical Research
-
-
Delaware
-
Newark, Delaware, Yhdysvallat, 19713
- Christiana Care Research Institute
-
-
Florida
-
Delray Beach, Florida, Yhdysvallat, 33445
- Brain Matters Research
-
Fort Myers, Florida, Yhdysvallat, 33912
- Neuropsychiatric Research Center of Southwest Florida
-
Hollywood, Florida, Yhdysvallat, 33021
- Sunrise Clinical Research
-
Jacksonville, Florida, Yhdysvallat, 32256
- Clinical NeuroScience Solutions Inc
-
Miami, Florida, Yhdysvallat, 33137
- Miami Jewish Health Systems
-
Miami Beach, Florida, Yhdysvallat, 33140
- Mount Sinai Medical Center
-
New Port Richey, Florida, Yhdysvallat, 34652
- Suncoast Clinical Research
-
Ocoee, Florida, Yhdysvallat, 34761
- Sensible Healthcare
-
Orlando, Florida, Yhdysvallat, 32806
- Compass Research
-
Pensacola, Florida, Yhdysvallat, 32502
- Pensacola Research Consultants, Inc.
-
Pompano Beach, Florida, Yhdysvallat, 33064
- Quantum Laboratories
-
Sarasota, Florida, Yhdysvallat, 34243
- Roskamp Institute
-
Tampa, Florida, Yhdysvallat, 33609
- Axiom Research
-
West Palm Beach, Florida, Yhdysvallat, 33407
- Premiere Research Institute at Palm Beach Neurology
-
-
Georgia
-
Atlanta, Georgia, Yhdysvallat, 30331
- Atlanta Center of Medical Research
-
Gainesville, Georgia, Yhdysvallat, 30501
- United Osteoporosis Center
-
-
Illinois
-
Champaign, Illinois, Yhdysvallat, 61820
- Christie Clinic, LLC
-
Elk Grove Village, Illinois, Yhdysvallat, 60007
- Alexian Brothers Medical Center
-
Winfield, Illinois, Yhdysvallat, 60190
- Central DuPage Hospital
-
-
Indiana
-
Fort Wayne, Indiana, Yhdysvallat, 46804
- Fort Wayne Neurological Center
-
Indianapolis, Indiana, Yhdysvallat, 46202
- Indiana University School of Medicine
-
Indianapolis, Indiana, Yhdysvallat, 46256
- Josephson Wallack Munshower Neurology
-
-
Kansas
-
Topeka, Kansas, Yhdysvallat, 66606
- Cotton O'Neil Clinic
-
Wichita, Kansas, Yhdysvallat, 67207
- Heartland Research Associates
-
-
Kentucky
-
Lexington, Kentucky, Yhdysvallat, 40503
- Baptist Health Medical Group
-
-
Louisiana
-
Lake Charles, Louisiana, Yhdysvallat, 70629
- Lake Charles Clinical Trials
-
-
Maine
-
Scarborough, Maine, Yhdysvallat, 04074
- Maine Neurology
-
-
Maryland
-
Baltimore, Maryland, Yhdysvallat, 21285
- Sheppard Pratt Health System
-
Baltimore, Maryland, Yhdysvallat, 21204
- Sheppard Pratt Health System
-
Baltimore, Maryland, Yhdysvallat, 21205
- Johns Hopkins University School of Medicine
-
Baltimore, Maryland, Yhdysvallat, 21208
- Pharmasite Research Inc
-
-
Massachusetts
-
Methuen, Massachusetts, Yhdysvallat, 01844
- ActivMed Practices & Research, Inc
-
Plymouth, Massachusetts, Yhdysvallat, 02360-4843
- Donald S Marks
-
-
Michigan
-
Farmington Hills, Michigan, Yhdysvallat, 48334
- Quest Research Institute
-
-
Mississippi
-
Hattiesburg, Mississippi, Yhdysvallat, 39401
- Hattiesburg Clinic
-
-
Missouri
-
Bolivar, Missouri, Yhdysvallat, 65613
- Clinvest
-
Chesterfield, Missouri, Yhdysvallat, 63141
- Clinical Research Professionals
-
Creve Coeur, Missouri, Yhdysvallat, 63141
- Millenium Psychiatric Associates LLC
-
Kansas City, Missouri, Yhdysvallat, 64111
- St Lukes Hospital
-
-
Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89113
- Las Vegas Medical Research
-
-
New Hampshire
-
Nashua, New Hampshire, Yhdysvallat, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
-
Portsmouth, New Hampshire, Yhdysvallat, 03801
- ActivMed Practices & Research, Inc
-
-
New Jersey
-
Eatontown, New Jersey, Yhdysvallat, 07724
- Memory Enhancement Center of America, Inc.
-
Monroe, New Jersey, Yhdysvallat, 08831
- Pyramid Clinical Research
-
Princeton, New Jersey, Yhdysvallat, 08540
- Princeton Medical Institute
-
Springfield, New Jersey, Yhdysvallat, 07081
- The Cognitive and Research Center of NJ
-
Toms River, New Jersey, Yhdysvallat, 08755
- Advanced Memory Research Institute of New Jersey
-
Toms River, New Jersey, Yhdysvallat, 08755
- Bio Behavioral Health
-
-
New York
-
Albany, New York, Yhdysvallat, 12206
- Albany Medical College
-
Staten Island, New York, Yhdysvallat, 10312
- Richmond Behavorial Associates
-
-
North Carolina
-
Charlotte, North Carolina, Yhdysvallat, 28270
- Alzheimer's Memory Center
-
Winston-Salem, North Carolina, Yhdysvallat, 27103
- Piedmont Medical Research
-
-
Ohio
-
Cincinnati, Ohio, Yhdysvallat, 45219
- University of Cincinnati Medical Center
-
Dayton, Ohio, Yhdysvallat, 45459
- Neurology Diagnostics, Inc.
-
Shaker Heights, Ohio, Yhdysvallat, 44122
- Insight Clinical Trials
-
-
Oregon
-
Portland, Oregon, Yhdysvallat, 97225
- Center for Cognitive Health
-
Portland, Oregon, Yhdysvallat, 97210
- Summit Research Network Inc
-
-
Pennsylvania
-
Abington, Pennsylvania, Yhdysvallat, 19090
- Abington Neurological Associates
-
Allentown, Pennsylvania, Yhdysvallat, 18104
- Lehigh Center for Clinical Research
-
Allentown, Pennsylvania, Yhdysvallat, 18103
- LeHigh Valley Hospital
-
Jenkintown, Pennsylvania, Yhdysvallat, 19046
- Clinical Trial Center, LLC, Psychiatry
-
Plains, Pennsylvania, Yhdysvallat, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
-
-
Rhode Island
-
East Providence, Rhode Island, Yhdysvallat, 02914
- Rhode Island Mood & Memory Research Institute
-
Providence, Rhode Island, Yhdysvallat, 02906
- Butler Hospital
-
-
South Carolina
-
Indian Land, South Carolina, Yhdysvallat, 29707
- Metrolina Neurological Research Institute
-
-
Texas
-
Dallas, Texas, Yhdysvallat, 75231
- FutureSearch Trials
-
Dallas, Texas, Yhdysvallat, 75231
- Baylor AT&T Memory Center
-
Dallas, Texas, Yhdysvallat, 75219
- Baylor AT&T Memory Center
-
Houston, Texas, Yhdysvallat, 77030
- Houston Methodist
-
Houston, Texas, Yhdysvallat, 77054
- University of Texas Health Services Center - Houston
-
San Antonio, Texas, Yhdysvallat, 78229
- Clinical Trials of Texas, Inc.
-
San Antonio, Texas, Yhdysvallat, 78229
- Univ of Texas Health Science Center at San Antonio
-
-
Vermont
-
Bennington, Vermont, Yhdysvallat, 05201
- The Memory Clinic
-
-
Virginia
-
Norfolk, Virginia, Yhdysvallat, 23510
- Sentara Medical Group
-
Richmond, Virginia, Yhdysvallat, 23294
- National Clinical Research - Richmond
-
-
Washington
-
Kirkland, Washington, Yhdysvallat, 98034
- Evergreen Professional Plaza
-
-
Wisconsin
-
Middleton, Wisconsin, Yhdysvallat, 53562
- Dean Foundation for Health Research and Education
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
55 vuotta - 85 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
- Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
- Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
- Scores >0 on the Functional Activities Questionnaire (FAQ).
- Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.
Exclusion Criteria:
- Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
- Has known allergy to humanized monoclonal antibodies.
- Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
- Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
- Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
- Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Annettu IV
Muut nimet:
|
|
Kokeellinen: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
Annettu IV
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Aikaikkuna: Baseline, 24 Months
|
ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures.
The ADAS-Cog14 scale ranges from 0 to 90.
Higher scores indicate greater disease severity.
|
Baseline, 24 Months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Aikaikkuna: Baseline, 24 Months
|
The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs.
Total score ranges from 0 to 69; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Mini Mental Status Examination (MMSE)
Aikaikkuna: Baseline, 24 Months
|
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Aikaikkuna: Baseline, 24 Months
|
The MoCA will be used as the global cognitive screening instrument.
It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition.
Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Functional Activities Questionnaire (FAQ)
Aikaikkuna: Baseline, 24 Months
|
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media.
FAQ total score was calculated by adding the scores from each of the 10 items.
Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3).
The maximum FAQ total score is 30, with higher scores indicating greater impairment.
|
Baseline, 24 Months
|
|
Change From Baseline on the Neuropsychiatric Inventory (NPI)
Aikaikkuna: Baseline, 24 Months
|
The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the participant's behavior.
The score ranges from 12 to 144, with higher scores indicating greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Aikaikkuna: Baseline, 24 Months
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Aikaikkuna: Baseline, 24 Months
|
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
|
Baseline, 24 Months
|
|
Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Aikaikkuna: Baseline, 24 Months
|
The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Aikaikkuna: Baseline, 24 Months
|
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.
|
Baseline, 24 Months
|
|
Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Aikaikkuna: Baseline, 24 Months
|
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.
Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100.
Lower scores indicate greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)
Aikaikkuna: Baseline, 24 Months
|
QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment.
Each of 13 items rated on a 4-point scale.
Sum of items=total score (range: 13-52).
Higher scores=greater QoL.
|
Baseline, 24 Months
|
|
Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Aikaikkuna: Baseline, 24 Months
|
Concentration of amino acid peptide known as Aβ 1-42 in plasma.
|
Baseline, 24 Months
|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
Aikaikkuna: Baseline, 24 Months
|
MRI will be used to assess the effect of treatment on rate of whole brain volume.
|
Baseline, 24 Months
|
|
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
Aikaikkuna: Baseline, 24 Months
|
Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.
|
Baseline, 24 Months
|
|
Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins
Aikaikkuna: Baseline, 24 Months
|
Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
|
Baseline, 24 Months
|
|
Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Aikaikkuna: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Keskiviikko 1. kesäkuuta 2016
Ensisijainen valmistuminen (Todellinen)
Maanantai 1. toukokuuta 2017
Opintojen valmistuminen (Todellinen)
Maanantai 1. toukokuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 2. toukokuuta 2016
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 2. toukokuuta 2016
Ensimmäinen Lähetetty (Arvio)
Tiistai 3. toukokuuta 2016
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 10. lokakuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 25. syyskuuta 2019
Viimeksi vahvistettu
Sunnuntai 1. syyskuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 16349
- H8A-MC-LZBE (Muu tunniste: Eli Lilly and Company)
- 2016-000108-27 (EudraCT-numero)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-jaon aikakehys
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD-jaon käyttöoikeuskriteerit
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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