A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25 september 2019 bijgewerkt door: 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).
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
26
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Gatineau, Canada, J8T 8J1
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Greenfield Park, Canada, J4V 2J2
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Halifax, Canada, B3S1M7
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Kentville, Canada, B4N 4K9
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London, Canada, N6C 0A7
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Ottawa, Canada, KIN 5C8
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Peterborough, Canada, K9H2P4
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Sherbrooke, Canada, J1H1Z1
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Toronto, Canada, M3B 2S7
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Chemnitz, Duitsland, 09131
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Kuopio, Finland, 70210
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Oulu, Finland, 90100
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Tampere, Finland, 33100
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Turku, Finland, 20014
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Vaasa, Finland, 65130
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Amiens, Frankrijk, 80054
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Bordeaux, Frankrijk, 33076
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Bron, Frankrijk, 69677
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Lille, Frankrijk, 59037
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Marseille, Frankrijk, 13385
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Montpellier, Frankrijk, 34295
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Paris, Frankrijk, 75015
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Paris, Frankrijk, 75651
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Paris, Frankrijk, 75010
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Rennes, Frankrijk, 35033
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Strasbourg, Frankrijk, 67000
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Toulouse, Frankrijk, 31059
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Genova, Italië, 16132
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Milano, Italië, 20122
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Milano, Italië, 20133
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Monza, Italië, 20052
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Pavia, Italië, 27100
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Perugia, Italië, 06134
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Pisa, Italië, 56126
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Roma, Italië, 00161
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Roma, Italië, 00153
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Roma, Italië, 00179
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Roma, Italië, 00189
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Bunkyo-ku, Japan, 113-8655
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Bunkyo-ku, Japan, 113-8431
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Hachioji, Japan, 193-0998
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Hyogo, Japan, 673-0848
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Kamakura, Japan, 247-8533
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Kodaira-shi, Japan, 187-8551
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Koriyama, Japan, 963-8052
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Kyoto-shi, Japan, 607-8113
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Mitaka-shi, Japan, 181-0013
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Shinjuku-Ku, Japan, 160-8582
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Shizuoka, Japan, 424-0911
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Takamatsu, Japan, 760-8557
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Tokyo, Japan, 113-0034
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Tsu-shi, Japan, 514-8507
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Białystok, Polen, 15-732
- 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.
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Bydgoszcz, Polen, 85-796
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Lublin, Polen, 20-093
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Poznan, Polen, 30-856
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Sopot, Polen, 81-824
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Warszawa, Polen, 01-697
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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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Barcelona, Spanje, 08025
- 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.
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Barcelona, Spanje, 08036
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Barcelona, Spanje, 08014
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Castellon de la Plana, Spanje, 12004
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Getafe, Spanje, 28905
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Getxo, Spanje, 48993
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Madrid, Spanje, 28006
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Plasencia, Spanje, 10600
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Salt, Spanje, 17190
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San Sebastian, Spanje, 20009
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Valencia, Spanje, 46017
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Valencia, Spanje, 46026
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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, Verenigd Koninkrijk, BA1 3NG
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Chelsea, Verenigd Koninkrijk, W6 8RF
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Guildford, Verenigd Koninkrijk, GU2 7YD
- 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.
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London, Verenigd Koninkrijk, W1G 9RU
- 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.
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Manchester, Verenigd Koninkrijk, M13 9WL
- 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.
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Scotland, Verenigd Koninkrijk, G20 0XA
- 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.
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Verenigde Staten, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Verenigde Staten, 85004
- Xenoscience
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Sun City, Arizona, Verenigde Staten, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Verenigde Staten, 85718
- Center For Neurosciences
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Tucson, Arizona, Verenigde Staten, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Verenigde Staten, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Verenigde Staten, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Verenigde Staten, 92270
- Desert Valley Research
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San Diego, California, Verenigde Staten, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Verenigde Staten, 92103
- Pacific Research Network Inc
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San Francisco, California, Verenigde Staten, 94114
- California Pacific Medical Center
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Santa Ana, California, Verenigde Staten, 92705
- Apex Research Institute
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Santa Clarita, California, Verenigde Staten, 91321
- Care Access Research LLC
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Sherman Oaks, California, Verenigde Staten, 91403
- California Neuroscience Research
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Valencia, California, Verenigde Staten, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Verenigde Staten, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06510
- Yale University School Of Medicine
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Stamford, Connecticut, Verenigde Staten, 06905
- New England Institute for Clinical Research
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-
Delaware
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Newark, Delaware, Verenigde Staten, 19713
- Christiana Care Research Institute
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-
Florida
-
Delray Beach, Florida, Verenigde Staten, 33445
- Brain Matters Research
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Fort Myers, Florida, Verenigde Staten, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Verenigde Staten, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Verenigde Staten, 32256
- Clinical Neuroscience Solutions Inc
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Miami, Florida, Verenigde Staten, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Verenigde Staten, 33140
- Mount Sinai Medical Center
-
New Port Richey, Florida, Verenigde Staten, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Verenigde Staten, 34761
- Sensible Healthcare
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Orlando, Florida, Verenigde Staten, 32806
- Compass Research
-
Pensacola, Florida, Verenigde Staten, 32502
- Pensacola Research Consultants, Inc.
-
Pompano Beach, Florida, Verenigde Staten, 33064
- Quantum Laboratories
-
Sarasota, Florida, Verenigde Staten, 34243
- Roskamp Institute
-
Tampa, Florida, Verenigde Staten, 33609
- Axiom Research
-
West Palm Beach, Florida, Verenigde Staten, 33407
- Premiere Research Institute at Palm Beach Neurology
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-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30331
- Atlanta Center of Medical Research
-
Gainesville, Georgia, Verenigde Staten, 30501
- United Osteoporosis Center
-
-
Illinois
-
Champaign, Illinois, Verenigde Staten, 61820
- Christie Clinic, LLC
-
Elk Grove Village, Illinois, Verenigde Staten, 60007
- Alexian Brothers Medical Center
-
Winfield, Illinois, Verenigde Staten, 60190
- Central DuPage Hospital
-
-
Indiana
-
Fort Wayne, Indiana, Verenigde Staten, 46804
- Fort Wayne Neurological Center
-
Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University School of Medicine
-
Indianapolis, Indiana, Verenigde Staten, 46256
- Josephson Wallack Munshower Neurology
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-
Kansas
-
Topeka, Kansas, Verenigde Staten, 66606
- Cotton O'Neil Clinic
-
Wichita, Kansas, Verenigde Staten, 67207
- Heartland Research Associates
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40503
- Baptist Health Medical Group
-
-
Louisiana
-
Lake Charles, Louisiana, Verenigde Staten, 70629
- Lake Charles Clinical Trials
-
-
Maine
-
Scarborough, Maine, Verenigde Staten, 04074
- Maine Neurology
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21285
- Sheppard Pratt Health System
-
Baltimore, Maryland, Verenigde Staten, 21204
- Sheppard Pratt Health System
-
Baltimore, Maryland, Verenigde Staten, 21205
- Johns Hopkins University School Of Medicine
-
Baltimore, Maryland, Verenigde Staten, 21208
- Pharmasite Research Inc
-
-
Massachusetts
-
Methuen, Massachusetts, Verenigde Staten, 01844
- ActivMed Practices & Research, Inc
-
Plymouth, Massachusetts, Verenigde Staten, 02360-4843
- Donald S Marks
-
-
Michigan
-
Farmington Hills, Michigan, Verenigde Staten, 48334
- Quest Research Institute
-
-
Mississippi
-
Hattiesburg, Mississippi, Verenigde Staten, 39401
- Hattiesburg Clinic
-
-
Missouri
-
Bolivar, Missouri, Verenigde Staten, 65613
- Clinvest
-
Chesterfield, Missouri, Verenigde Staten, 63141
- Clinical Research Professionals
-
Creve Coeur, Missouri, Verenigde Staten, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Verenigde Staten, 64111
- St Lukes Hospital
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-
Nevada
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Las Vegas, Nevada, Verenigde Staten, 89113
- Las Vegas Medical Research
-
-
New Hampshire
-
Nashua, New Hampshire, Verenigde Staten, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
-
Portsmouth, New Hampshire, Verenigde Staten, 03801
- ActivMed Practices & Research, Inc
-
-
New Jersey
-
Eatontown, New Jersey, Verenigde Staten, 07724
- Memory Enhancement Center of America, Inc.
-
Monroe, New Jersey, Verenigde Staten, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Verenigde Staten, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Verenigde Staten, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Verenigde Staten, 08755
- Advanced Memory Research Institute of New Jersey
-
Toms River, New Jersey, Verenigde Staten, 08755
- Bio Behavioral Health
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-
New York
-
Albany, New York, Verenigde Staten, 12206
- Albany Medical College
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Staten Island, New York, Verenigde Staten, 10312
- Richmond Behavorial Associates
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-
North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Verenigde Staten, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Verenigde Staten, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Verenigde Staten, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Verenigde Staten, 97225
- Center for Cognitive Health
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Portland, Oregon, Verenigde Staten, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Verenigde Staten, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Verenigde Staten, 18104
- Lehigh Center For Clinical Research
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Allentown, Pennsylvania, Verenigde Staten, 18103
- LeHigh Valley Hospital
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Jenkintown, Pennsylvania, Verenigde Staten, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Verenigde Staten, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Verenigde Staten, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Verenigde Staten, 02906
- Butler Hospital
-
-
South Carolina
-
Indian Land, South Carolina, Verenigde Staten, 29707
- Metrolina Neurological Research Institute
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Texas
-
Dallas, Texas, Verenigde Staten, 75231
- FutureSearch Trials
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Dallas, Texas, Verenigde Staten, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Verenigde Staten, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Verenigde Staten, 77030
- Houston Methodist
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Houston, Texas, Verenigde Staten, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Verenigde Staten, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Verenigde Staten, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Verenigde Staten, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23510
- Sentara Medical Group
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Richmond, Virginia, Verenigde Staten, 23294
- National Clinical Research - Richmond
-
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Washington
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Kirkland, Washington, Verenigde Staten, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Verenigde Staten, 53562
- Dean Foundation for Health Research and Education
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-
-
-
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Malmö, Zweden, 20502
- 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.
-
Mölndal, Zweden, 43141
- 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.
-
Stockholm, Zweden, 113 61
- 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.
-
Umeå, Zweden, 90105
- 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.
-
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
IV toegediend
Andere namen:
|
|
Experimenteel: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
IV toegediend
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2016
Primaire voltooiing (Werkelijk)
1 mei 2017
Studie voltooiing (Werkelijk)
1 mei 2017
Studieregistratiedata
Eerst ingediend
2 mei 2016
Eerst ingediend dat voldeed aan de QC-criteria
2 mei 2016
Eerst geplaatst (Schatting)
3 mei 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 oktober 2019
Laatste update ingediend die voldeed aan QC-criteria
25 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 16349
- H8A-MC-LZBE (Andere identificatie: Eli Lilly and Company)
- 2016-000108-27 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .