- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06653153
En undersøgelse af Remternetug i tidlig Alzheimers sygdom
En undersøgelse af Remternetug versus placebo hos deltagere i tidlig Alzheimers sygdom med risiko for kognitiv og funktionel tilbagegang
Formålet med denne undersøgelse er at måle forskellen i tid til udvikling eller forværring af hukommelse, tænkning eller funktionelle problemer på grund af Alzheimers sygdom, der forekommer hos deltagere, der får studielægemiddel sammenlignet med placebo.
Deltagelse kan vare op til 255 uger inklusive screening, en dobbeltblind behandlingsperiode og en dobbeltblind observationsperiode. Derudover kan berettigede deltagere, der modtager placebo i den dobbeltblindede behandlingsperiode, vælge at forlænge deres studiedeltagelse for at modtage open-label remternetug i en forlængelsesperiode.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Birtinya, Australien, 4575
- USC Clinical Trials Sunshine Coast
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Botany, Australien, 2019
- Emeritus Research
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Box Hill, Australien, 3128
- Box Hill Hospital
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Camberwell, Australien, 3124
- Emeritus Research
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East Maitland, Australien, 2323
- GenesisCare - Maitland
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Herston, Australien, 4029
- The University of Queensland
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Ipswich, Australien, 4305
- Ipswich Hospital
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Ivanhoe, Australien, 3079
- Austin Health
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Kogarah, Australien, 2217
- Southern Neurology
-
Macquarie Park, Australien, 2113
- KARA Institute for Neurological Diseases
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Malvern, Australien, 3144
- HammondCare
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Norwood, Australien, 5067
- Fusion Clinical Research
-
Parkville, Australien, 3050
- The Royal Melbourne Hospital
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South Brisbane, Australien, 4101
- USC Clinical Trials Brisbane (South Bank)
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Sydney, Australien, 2010
- St Vincent's Hospital
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Woodville, Australien, 5011
- The Queen Elizabeth Hospital
-
-
-
-
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Chicoutimi, Canada, G7H 0S7
- Ecogene-21 - Cmas
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Greenfield Park, Canada, J4V 2J2
- MoCA Research and Innovation Inc.
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Kelowna, Canada, V1Y 1Z9
- OCT Research ULC
-
Lévis, Canada, G6V 0C9
- Alpha Recherche Clinique - Lévis
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Montreal, Canada, H3G 1H9
- Clinique Memoire de Montreal
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Montreal, Canada, H4A 3T2
- Genge Partners
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Ottawa, Canada, K1Z 1G3
- Ottawa Memory Clinic
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Peterborough, Canada, K9H 2P4
- Kawartha Centre - Redefining Healthy Aging
-
Québec, Canada, G3K 2P8
- ALPHA Recherche Clinique
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Québec, Canada, G2J 0C4
- ALPHA Recherche Clinique
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Sarnia, Canada, N7T 4X3
- Bluewater Clinical Research Group Inc.
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Sherbrooke, Canada, J1J 2G2
- Q&T Research Sherbrooke Inc.
-
Toronto, Canada, M3B 2S7
- Toronto Memory Program
-
Toronto, Canada, M4N 3M5
- Sunnybrook Research Institute
-
Toronto, Canada, M6A 2E1
- Baycrest Health Sciences
-
Victoriaville, Canada, G6P 3Z8
- Diex Recherche Inc. Division Victoriaville
-
West Vancouver, Canada, V7T 1C5
- The Medical Arts Health Research Group - West Vancouver
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-
-
-
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Bath, Det Forenede Kongerige, BA1 3NG
- ReMind UK
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Birmingham, Det Forenede Kongerige, B16 8LT
- Re:Cognition Health - Birmingham
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Blackpool, Det Forenede Kongerige, FY3 7EN
- Layton Medical Centre
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Edinburgh, Det Forenede Kongerige, EH12 5PJ
- Scottish Brain Sciences
-
London, Det Forenede Kongerige, EC2Y 8EA
- St Pancras Clinical Research
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Manchester, Det Forenede Kongerige, M13 9WL
- NIHR Manchester Clinical Research Facility
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Motherwell, Det Forenede Kongerige, ML1 4UF
- NeuroClin
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Plymouth, Det Forenede Kongerige, PL6 6PH
- Roborough Surgery
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Redruth, Det Forenede Kongerige, TR16 4ET
- Homecroft Surgery
-
Romsey, Det Forenede Kongerige, SO51 7QN
- Abbeywell Surgery
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Southampton, Det Forenede Kongerige, SO30 3JB
- Moorgreen Hospital
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West Kirby, Det Forenede Kongerige, CH48 5AA
- Marine Lake Medical Practice
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-
-
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Alabama
-
Birmingham, Alabama, Forenede Stater, 35215
- Parkway Medical Center
-
-
Arizona
-
Chandler, Arizona, Forenede Stater, 85286
- MD First Research - Chandler
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Mesa, Arizona, Forenede Stater, 85206
- Care Access - 801 South Power Road, Mesa
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Phoenix, Arizona, Forenede Stater, 85006
- Banner Alzheimer's Institute
-
Tucson, Arizona, Forenede Stater, 85718
- Banner Alzheimer's Institute Tucson
-
-
California
-
Fresno, California, Forenede Stater, 93710
- Neuro-Pain Medical Center
-
Huntington Beach, California, Forenede Stater, 92648
- Care Access - Huntington Beach
-
Inglewood, California, Forenede Stater, 90301
- Inglewood Clinical
-
Irvine, California, Forenede Stater, 92614
- Irvine Clinical Research
-
Long Beach, California, Forenede Stater, 90804
- Healthy Brain Clinic
-
Riverside, California, Forenede Stater, 92506
- Riverside Clinical
-
Sacramento, California, Forenede Stater, 95821
- Clinical Trials Research
-
San Diego, California, Forenede Stater, 92103
- Artemis Institute for Clinical Research
-
San Diego, California, Forenede Stater, 92123
- Sharp Neurocognitive Research Center
-
San Francisco, California, Forenede Stater, 94114
- Ray Dolby Brain Health Center
-
San Marcos, California, Forenede Stater, 92069
- The Neuron Clinic - San Marcos
-
Santa Ana, California, Forenede Stater, 92705
- Syrentis Clinical Research
-
Santa Rosa, California, Forenede Stater, 95403
- Providence Medical Foundation
-
Sherman Oaks, California, Forenede Stater, 91403
- California Neuroscience Research, LLC
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80012
- Care Access - Aurora
-
Basalt, Colorado, Forenede Stater, 81621
- Mountain Neurological Research Center
-
Boulder, Colorado, Forenede Stater, 80301
- Alpine Clinical Research Center
-
Englewood, Colorado, Forenede Stater, 80113
- CenExel Rocky Mountain Clinical Research
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06510
- Invicro
-
Stamford, Connecticut, Forenede Stater, 06905
- Ki Health Partners, LLc, dba New England Institute for Clinical Research
-
-
Florida
-
Atlantis, Florida, Forenede Stater, 33462
- JEM Research Institute
-
Aventura, Florida, Forenede Stater, 33180
- VIN - Aventura
-
Bradenton, Florida, Forenede Stater, 34205
- Bradenton Research Center, Inc.
-
Clermont, Florida, Forenede Stater, 34711
- K2 Medical Research Winter Garden
-
Davie, Florida, Forenede Stater, 33024
- TecTum Research
-
Delray Beach, Florida, Forenede Stater, 33445
- Brain Matters Research
-
Fort Myers, Florida, Forenede Stater, 33912
- Neuropsychiatric Research Center of Southwest Florida
-
Hialeah, Florida, Forenede Stater, 33012
- Indago Research & Health Center, Inc
-
Lady Lake, Florida, Forenede Stater, 32159
- K2 MEDICAL Research THE VILLAGES
-
Maitland, Florida, Forenede Stater, 32751
- ClinCloud
-
Maitland, Florida, Forenede Stater, 32751
- K2 Medical Research ORLANDO
-
Melbourne, Florida, Forenede Stater, 32940
- ClinCloud
-
Merritt Island, Florida, Forenede Stater, 32952
- Merritt Island Medical Research, LLC
-
Miami, Florida, Forenede Stater, 33186
- New Age Medical Research Corporation
-
Miami, Florida, Forenede Stater, 33133
- VIN-Andrew Lerman
-
Mt. Dora, Florida, Forenede Stater, 32757
- Adult Medicine of Lake County, Inc.
-
Naples, Florida, Forenede Stater, 34105
- Aqualane Clinical Research
-
New Port Richey, Florida, Forenede Stater, 34652
- Suncoast Clinical Research, Inc.
-
Ocala, Florida, Forenede Stater, 34470
- Renstar Medical Research
-
Orlando, Florida, Forenede Stater, 32804
- AdventHealth Orlando
-
Orlando, Florida, Forenede Stater, 32803
- Charter Research - Winter Park
-
Pensacola, Florida, Forenede Stater, 32504
- Emerald Coast Neurology - Airport Boulevard
-
Port Orange, Florida, Forenede Stater, 32127
- Progressive Medical Research
-
Stuart, Florida, Forenede Stater, 34997
- Alzheimer's Research and Treatment Center
-
Tampa, Florida, Forenede Stater, 33613
- Stedman Clinical Trials
-
Tampa, Florida, Forenede Stater, 33625
- Care Access - Tampa
-
Tampa, Florida, Forenede Stater, 33609
- Axiom Brain Health LLC
-
The Villages, Florida, Forenede Stater, 32162
- Charter Research - Lady Lake
-
Wellington, Florida, Forenede Stater, 33414
- Alzheimer's Research and Treatment Center
-
West Palm Beach, Florida, Forenede Stater, 33407
- Palm Beach Neurology
-
Winter Park, Florida, Forenede Stater, 32789
- Conquest Research
-
-
Georgia
-
Columbus, Georgia, Forenede Stater, 31909
- Columbus Memory Center, LLC
-
Decatur, Georgia, Forenede Stater, 30030
- Care Access - Decatur
-
Gainesville, Georgia, Forenede Stater, 30501
- Center for Advanced Research & Education
-
Woodstock, Georgia, Forenede Stater, 30189
- North Georgia Clinical Research
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83704
- Northwest Clinical Trials
-
-
Illinois
-
Arlington Heights, Illinois, Forenede Stater, 60005
- Care Access - Arlington Heights
-
Chicago, Illinois, Forenede Stater, 60640
- Great Lakes Clinical Trials - Andersonville
-
Chicago, Illinois, Forenede Stater, 60611
- Re:Cognition Health - Chicago
-
Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Medical Center
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46256
- Josephson Wallack Munshower Neurology, PC
-
Indianapolis, Indiana, Forenede Stater, 46227
- Care Access - South Indianapolis
-
-
Iowa
-
Waterloo, Iowa, Forenede Stater, 50701
- Cedar Valley Medical Specialists
-
-
Kansas
-
Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Clinical Research Center
-
-
Louisiana
-
Lake Charles, Louisiana, Forenede Stater, 70601
- Care Access - Lake Charles (Bayou Pines)
-
Marrero, Louisiana, Forenede Stater, 70072
- Tandem Clinical Research
-
-
Maine
-
Bangor, Maine, Forenede Stater, 04401
- Acadia Hospital
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21213
- Care Access - Baltimore
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02131
- Boston Clinical Trials
-
Boston, Massachusetts, Forenede Stater, 02116
- Adams Clinical Boston
-
Newton, Massachusetts, Forenede Stater, 02459
- Boston Center for Memory
-
Quincy, Massachusetts, Forenede Stater, 02169
- Care Access - Quincy
-
Waltham, Massachusetts, Forenede Stater, 02451
- MedVadis Research Corporation
-
Watertown, Massachusetts, Forenede Stater, 02472
- Adams Clinical Watertown
-
-
Michigan
-
Dearborn, Michigan, Forenede Stater, 48126
- Revival Research Institute, LLC
-
Farmington Hills, Michigan, Forenede Stater, 48334
- QUEST Research Institute
-
-
Minnesota
-
Saint Paul, Minnesota, Forenede Stater, 55130
- HealthPartners Neuroscience Center
-
-
Mississippi
-
Hattiesburg, Mississippi, Forenede Stater, 39401
- Private Practice - Dr. Ronald Louis Schwartz
-
-
Missouri
-
Bolivar, Missouri, Forenede Stater, 65613
- Citizens Memorial Hospital District
-
Chesterfield, Missouri, Forenede Stater, 63005
- Clinical Research Professionals
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68198
- University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89128
- Vector Clinical Trials
-
-
New Jersey
-
Hoboken, New Jersey, Forenede Stater, 07030
- Care Access - Hoboken
-
Ridgewood, New Jersey, Forenede Stater, 07450
- The Cognitive and Research Center of New Jersey - Ridgewood
-
Springfield, New Jersey, Forenede Stater, 07081
- The Cognitive and Research Center of New Jersey
-
Toms River, New Jersey, Forenede Stater, 08755
- Advanced Memory Research Institute of New Jersey
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87109
- IMA Clinical Research
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28210
- Care Access - Charlotte
-
Greensboro, North Carolina, Forenede Stater, 27405
- Medication Management
-
Monroe, North Carolina, Forenede Stater, 28112
- Monroe Biomedical Research
-
-
Ohio
-
Lima, Ohio, Forenede Stater, 45805
- Care Access - Lima
-
Middleburg Heights, Ohio, Forenede Stater, 44130
- North Star Medical Research
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97210
- Summit Headlands
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19114
- Clinical Research of Philadelphia
-
Plymouth Meeting, Pennsylvania, Forenede Stater, 19462
- Keystone Clinical Studies
-
-
Rhode Island
-
East Providence, Rhode Island, Forenede Stater, 02914
- Rhode Island Mood & Memory Research Institute
-
Providence, Rhode Island, Forenede Stater, 02906
- Butler Hospital
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29607
- Tribe Clinical Research, LLC- Greenville
-
Summerville, South Carolina, Forenede Stater, 29485
- Palmetto Clinical Research
-
-
Tennessee
-
Cordova, Tennessee, Forenede Stater, 38018
- Neurology Clinic, P.C.
-
Knoxville, Tennessee, Forenede Stater, 37909
- Genesis Neuroscience Clinic
-
-
Texas
-
Austin, Texas, Forenede Stater, 78757
- Senior Adults Specialty Research
-
Beaumont, Texas, Forenede Stater, 77702
- Gadolin Research
-
Dallas, Texas, Forenede Stater, 75231
- Kerwin Medical Center
-
Dallas, Texas, Forenede Stater, 75216
- Kerwin Medical Center - Oak Cliff
-
Georgetown, Texas, Forenede Stater, 78633
- Care Access - Georgetown
-
Houston, Texas, Forenede Stater, 77054
- The University of Texas Health Science Center at Houston
-
Houston, Texas, Forenede Stater, 77057
- Next Level Urgent Care
-
Houston, Texas, Forenede Stater, 77054
- Care Access - Houston
-
Rio Grande City, Texas, Forenede Stater, 78582
- El Faro Health and Therapeutics
-
Round Rock, Texas, Forenede Stater, 78681
- Central Texas Neurology Consultants, PA
-
San Antonio, Texas, Forenede Stater, 78229
- IMA Clinical Research San Antonio
-
Shavano Park, Texas, Forenede Stater, 78231
- Consano Clinical Research, LLC
-
-
Virginia
-
Arlington, Virginia, Forenede Stater, 22206
- Care Access - Arlington 2
-
Fairfax, Virginia, Forenede Stater, 22031
- Re:Cognition Health
-
Norfolk, Virginia, Forenede Stater, 23510
- Eastern Virginia Medical School (EVMS) Medical Group
-
-
Washington
-
Bellevue, Washington, Forenede Stater, 98007
- Northwest Clinical Research Center
-
Renton, Washington, Forenede Stater, 98057
- Rainier Clinical Research Center
-
-
-
-
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Bunkyō City, Japan, 113-8655
- The University of Tokyo Hospital
-
Chūōku, Japan, 103-0027
- Tokyo-Eki Center-building Clinic
-
Chūōku, Japan, 103-0027
- Medical Corporation Chiseikai Tokyo Center Clinic
-
Chūōku, Japan, 104-0031
- Fukuwa Clinic
-
Chūōku, Japan, 104-0031
- Tokyo Asbo Clinic
-
Fujisawa, Japan, 251-0038
- Kawashima Neurology Clinic
-
Fukuoka, Japan, 812-0025
- Boocs Clinic Fukuoka
-
Fukuoka, Japan, 812-0018
- UNB Sumiyoshi Jinjamae Clinic
-
Hachiōji, Japan, 192-0071
- P-One Clinic
-
Himeji, Japan, 670-8560
- Hyogo Prefectural Harima-Himeji General Medical Center
-
Imabari, Japan, 799-1592
- Saiseikai Imabari Hospital
-
Kobe, Japan, 650-0017
- Kobe University Hospital
-
Kodaira, Japan, 187-8510
- Showa General Hospital
-
Kyoto, Japan, 600-8811
- Tatsuoka Neurology Clinic
-
Minatoku, Japan, 106-0032
- Sakurazaka Clinic SophyAnce
-
Osaka, Japan, 536-0007
- Iwata Neurosurgery Clinic
-
Setagaya-ku, Japan, 158-8531
- Kanto Central Hospital
-
Shinjuku, Japan, 160-0017
- Samoncho Clinic
-
Shinjuku-ku, Japan, 160-0004
- Clinical Research Hospital Tokyo
-
Shinjuku-ku, Japan, 160-0008
- Heishinkai Medical Group ToCROM Clinic
-
Shinjuku-ku, Japan, 169-0072
- Higashi Shinjuku Clinic
-
Suita-shi, Japan, 565-0853
- Medical Corporation Heishinkai OCROM Clinic
-
Tachikawa, Japan, 190-8531
- Tachikawa Hospital
-
Takatsuki-shi, Japan, 569-1192
- Takatsuki Hospital
-
Wako, Japan, 351-0111
- Wako Hospital
-
tabashi City, Japan, 173-0015
- Tokyo Metropolitan Geriatric Hospital
-
Ōbu, Japan, 474-8511
- National Center for Geriatrics and Gerontology
-
-
-
-
-
Beijing, Kina, 100071
- Beijing Tiantan Hospital Affiliated to Capital Medical University
-
Beijing, Kina, 100088
- Beijing Anding Hospital - Affiliated Capital University of Medical Science
-
Changchun, Kina, 100012
- The First Hospital of Jilin University
-
Changsha, Kina, 410008
- Xiangya Hospital Central South University
-
Chengdu, Kina, 610072
- Sichuan Provincial People's Hospital
-
Guangzhou, Kina, 510080
- Guangdong Provincial People's Hospital
-
Guangzhou, Kina, 510180
- Guangzhou First People's Hospital
-
Guangzhou, Kina, 510280
- Zhujiang Hospital
-
Guangzhou, Kina, 510260
- Guangzhou Medical University 2nd Hospital
-
Hefei, Kina, 230036
- Anhui Provincial Hospital
-
Jinan, Kina, 250013
- Jinan Central Hospital
-
Luoyang, Kina, 471003
- The First Affiliated Hospital of Henan University of Science &Technology
-
Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
-
Nanchang, Kina, 330000
- The Second Affiliated Hospital of Nanchang University
-
Nanjing, Kina, 210029
- Nanjing Brain Hospital
-
Nanjing, Kina, 211166
- Sir Run Run Hospital of Nanjing Medical University
-
Shanghai, Kina, 200040
- Huashan Hospital, Fudan University
-
Shanghai, Kina, 201200
- Pudong New Area People's Hospital Shanghai
-
Shanghai, Kina, 200030
- Shanghai sixth people's hospital
-
Shanghai, Kina, 200135
- Renji Hospital Shanghai Jiao Tong University School of Medicine
-
Shijiazhuang, Kina, 050031
- The First Hospital of Hebei Medical University
-
Suzhou, Kina, 215004
- The Second Affiliated Hospital of Soochow University
-
Tianjin, Kina, 300052
- Tianjin Medical University General Hospital
-
Xi'an, Kina, 710077
- The First Affiliated Hospital of Xi'an Medical University
-
Xi'an, Kina, 710068
- Shaanxi provincial people's hospital
-
Xianyang, Kina, 712000
- Xianyang Hospital of Yan'an University
-
Xuzhou, Kina, 221006
- The Affiliated Hospital of Xuzhou Medical College
-
Xuzhou, Kina, 221018
- Xuzhou Central Hospital
-
Zigong, Kina, 643000
- Zigong First People's Hospital
-
-
-
-
-
Bayamón, Puerto Rico, 00961
- SCB Research Center
-
San Juan, Puerto Rico, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
-
San Juan, Puerto Rico, 00918
- INSPIRA Clinical Research
-
San Juan, Puerto Rico, 00918
- Caribbean Medical Research Center
-
-
-
-
-
Barcelona, Spanien, 08036
- Hospital Clínic de Barcelona
-
Barcelona, Spanien, 08041
- Hospital de la Santa Creu i Sant Pau
-
Barcelona, Spanien, 08005
- Barcelonabeta Brain Research Center
-
Barcelona, Spanien, 08028
- Fundaciò ACE
-
Pozuelo de Alarcón, Spanien, 28223
- Hospital Universitario Quironsalud Madrid
-
San Sebastián, Spanien, 20014
- Policlinica Gipuzkoa
-
Seville, Spanien, 41009
- Hospital Victoria Eugenia
-
-
-
-
-
Busan, Sydkorea, 49241
- Pusan National University Hospital
-
Cheongju-si, Sydkorea, 28644
- Chungbuk National University Hospital
-
Gangnam-gu, Sydkorea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Gangseo-gu, Sydkorea, 07804
- Ewha Womans University Seoul Hospital
-
Gwangju, Sydkorea, 61469
- Chonnam National University Hospital
-
Incheon, Sydkorea, 22332
- Inha University Hospital
-
Jeju City, Sydkorea, 63241
- Jeju National University Hospital
-
Namdong-gu, Sydkorea, 21565
- Gachon University Gil Medical Center
-
Seongnam, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 06351
- Samsung Medical Center
-
Seoul, Sydkorea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
-
Seoul, Sydkorea, 05030
- Konkuk University Medical Center
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital
-
Suwon, Sydkorea, 16499
- Ajou University Hospital
-
Wŏnju, Sydkorea, 26426
- Wonju Severance Christian Hospital
-
-
-
-
-
Changhua County, Taiwan, 50006
- Changhua Christian Hospital
-
Douliu, Taiwan, 640
- National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
-
Kaohsiung Niao Sung Dist, Taiwan, 83301
- Chang Gung Memorial Hospital at Kaohsiung
-
New Taipei City, Taiwan, 235
- Taipei Medical University Shuang Ho Hospital
-
New Taipei City, Taiwan, 236
- New Taipei Municipal TuCheng Hospital
-
Taichung, Taiwan, 407
- Taichung Veterans General Hospital
-
Taichung, Taiwan, 404332
- China Medical University Hospital
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taoyuan District, Taiwan, 333
- Chang Gung Medical Foundation-Linkou Branch
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Få et phosphoryleret tau (P-tau) resultat i overensstemmelse med tilstedeværelsen af amyloidpatologi.
- Har en pålidelig studiepartner og backup studiepartner, der er fortrolig med overordnet funktion og adfærd, såsom daglige aktiviteter og kognitive evner.
- Har tilstrækkelig læsefærdighed, syn og hørelse til neuropsykologisk test ved screening.
- Få en Mini Mental Status Exam (MMSE)-score i overensstemmelse med nej til minimal kognitiv svækkelse.
- Har en Functional Activities Questionnaire (FAQ)-score, der stemmer overens med nej til minimal funktionsnedsættelse.
- Hvis du i øjeblikket modtager medicin som symptomatisk behandling for AD, har dosis været stabil i mindst 30 dage før screening.
Ekskluderingskriterier:
- Har demens eller væsentlig anden neurologisk sygdom, der kan påvirke kognitionen.
- Har aktuelle alvorlige eller ustabile sygdomme, der efter investigators mening kan forstyrre undersøgelsens analyser.
- Har en historie med kræft, der efter efterforskerens mening har en høj risiko for tilbagefald.
- Har en historie med klinisk signifikante multiple eller svære lægemiddelallergier eller overfølsomhedsreaktioner.
- Få et klinisk vigtigt laboratorietestresultat eller en anden abnormitet som bestemt af investigator, som kan være skadelig for deltageren eller kan kompromittere undersøgelsen.
- Har nogen kontraindikationer for magnetisk resonansbilleddannelse (MRI).
- Få en central aflæst MR, der viser tilstedeværelsen af ARIA-E, >4 cerebrale mikroblødninger, enhver overfladisk siderose, enhver makroblødning eller alvorlig hvid substans sygdom ved screening.
Tidligere eller nuværende terapier
- Har tidligere haft behandling med en passiv anti-amyloid immunterapi inden for <5 halveringstider før screening.
- Har modtaget aktiv immunisering mod Aβ i enhver anden undersøgelse.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo administreret SC.
|
Administreret SC
|
|
Eksperimentel: Remternetug
Remternetug administreret subkutant (SC).
|
Administreret SC
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til klinisk meningsfuld progression målt ved klinisk demenshastighedsskala (CDR)
Tidsramme: Baseline til tid til begivenhed op til uge 255
|
Tid til klinisk meningsfuld progression målt ved CDR.
CDR er en kliniker-klassificeret skala, der giver en samlet vurdering af deltagerens scene og grad af værdiforringelse på tværs af kontinuummet i den tidlige Alzheimers sygdom (AD).
|
Baseline til tid til begivenhed op til uge 255
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline i Clinical Dementia Rate Box Score (SB)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i Clinical Dementia Rate Box Score (SB)-score varierer fra 0 til 18, med højere score, der indikerer mere svækkelse.
|
Baseline, uge 255
|
|
Ændring fra baseline i Montreal Cognitive Assessment (MoCA)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i Montreal Cognitive Assessment (MoCA).
Samlet MoCA-score er 0 til 30, med lavere score, der indikerer større niveau af værdiforringelse.
|
Baseline, uge 255
|
|
Skift fra baseline i kategorien flydende - sprog, eksekutiv funktion, semantisk hukommelse
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i kategorien flydende - sprog, eksekutiv funktion, semantisk hukommelse.
Den samlede score afspejler summen af korrekte svar genereret på tværs af alle præsenterede kategorier, med højere værdier, der indikerer bedre ydeevne.
|
Baseline, uge 255
|
|
Ændring fra baseline i Continuous Paired Associate Learning (CPAL)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i Continuous Paired Associate Learning (CPAL) - Visuel episodisk hukommelse.
|
Baseline, uge 255
|
|
Ændring fra baseline i International Shopping List Test (ISLT) - Verbal Episodic Mem
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i International Shopping List Test (ISLT) - verbal episodisk hukommelse.
|
Baseline, uge 255
|
|
Ændring fra baseline i International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i International Daily Symbol Substitution Test-Medicines (iDSSTm) - kompleks opmærksomhedshukommelse.
|
Baseline, uge 255
|
|
Ændring fra baseline i kognitivt funktionsindeks (CFI)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i Cognitive Function Index (CFI).
|
Baseline, uge 255
|
|
Ændring fra baseline i tjekliste for mild adfærdsnedsættelse (MBI-C)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i tjeklisten for mild adfærdssvækkelse (MBI-C) MBI-C's samlede score er 0 til 102, med højere score, der indikerer større svækkelse.
|
Baseline, uge 255
|
|
Ændring fra baseline i Alzheimers Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)
Tidsramme: Baseline, uge 255
|
Ændring fra baseline i Activities of Daily Living - Prevention Instruments samlede score varierer fra 0 til 54, med højere score, der indikerer bedre ydeevne.
|
Baseline, uge 255
|
|
Farmakokinetik: Serumkoncentrationer af Remternetug
Tidsramme: Baseline til og med uge 255
|
PK: serumkoncentration af remternetug.
|
Baseline til og med uge 255
|
|
Antal deltagere med Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Tidsramme: Baseline til og med uge 255
|
Antal deltagere med behandlingsfremkaldende antistof-antistoffer (TE-ADA).
|
Baseline til og med uge 255
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27183
- J1G-MC-LAKI (Anden identifikator: Eli Lilly and Company)
- 2024-515656-20-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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