A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Sponsor
Biogen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04241068
Collaborator
(none)
1,696
297
1
59.4
5.7
0.1
Study Details
Study Description
Brief Summary
The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1696 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Actual Study Start Date
:
Mar 13, 2020
Anticipated Primary Completion Date
:
Oct 11, 2023
Anticipated Study Completion Date
:
Feb 24, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aducanumab Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period. |
Drug: Aducanumab
Administered as specified in the treatment arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Week 100]
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
- Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal [Up to Week 100]
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E) [Up to Week 100]
Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.
- Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) [Up to Week 100]
MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.
- Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum [Up to Week 100]
Presence of serum ADAs will be determined using a validated assay.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
Core Treatment Period:
-
Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
-
Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.
LTE Treatment Period:
-
Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator.
-
Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.
Key Exclusion Criteria:
Core Treatment Period:
-
Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
-
Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
-
Clinically significant unstable psychiatric illness in past 6 months.
-
History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
-
A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
-
Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
-
History of or known seropositivity for HIV.
-
Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
-
Contraindications to having a brain magnetic resonance imaging (MRI).
LTE Treatment Period:
- Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study.
Note- Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 3 | Dignity Health | Phoenix | Arizona | United States | 85013 |
| 4 | Banner Sun Health Research Institute | Sun City | Arizona | United States | 85351 |
| 5 | Center for Neurosciences | Tucson | Arizona | United States | 85718 |
| 6 | Neurology Center of North Orange County | Fullerton | California | United States | 92835 |
| 7 | UCI MIND | Irvine | California | United States | 92607 |
| 8 | University of California San Diego Medical Center | La Jolla | California | United States | 92037 |
| 9 | Senior Clinical Trials, Inc. | Laguna Hills | California | United States | 92653 |
| 10 | USC Keck School of Medicine | Los Angeles | California | United States | 90033 |
| 11 | Mary S. Easton Center for Alzheimer's Disease Research, UCLA | Los Angeles | California | United States | 90095 |
| 12 | Pacific Neuroscience Medical Group | Oxnard | California | United States | 93030 |
| 13 | Stanford Hospital and Clinics | Palo Alto | California | United States | 94304 |
| 14 | Anderson Clinical Research | Redlands | California | United States | 92374 |
| 15 | Pacific Research Network, Inc | San Diego | California | United States | 92103 |
| 16 | UCSF - Memory and Aging Center | San Francisco | California | United States | 94143 |
| 17 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
| 18 | California Neuroscience Research Medical Group Inc. | Sherman Oaks | California | United States | 91403 |
| 19 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
| 20 | IMMUNOe International Research Centers | Centennial | Colorado | United States | 80112 |
| 21 | Yale University | Fairfield | Connecticut | United States | 06824 |
| 22 | Invicro | New Haven | Connecticut | United States | 06510 |
| 23 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06510 |
| 24 | Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | United States | 06851 |
| 25 | Georgetown University Clinical Research Unit (CRU) | Washington | District of Columbia | United States | 20007 |
| 26 | JEM Research | Atlantis | Florida | United States | 33462 |
| 27 | Bradenton Research Center, Inc | Bradenton | Florida | United States | 34205 |
| 28 | Brain Matters Research | Delray Beach | Florida | United States | 334405 |
| 29 | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | United States | 33912 |
| 30 | Infinity Clinical Research, LLC | Hollywood | Florida | United States | 33024 |
| 31 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 32 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 33462 |
| 33 | University of Miami | Miami | Florida | United States | 33136 |
| 34 | Miami Jewish Health System, Inc | Miami | Florida | United States | 33180 |
| 35 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
| 36 | Accelerated Enrollment Solutions (AES) | Orlando | Florida | United States | 32162 |
| 37 | Clinical Neuroscience Solutions, Inc. | Orlando | Florida | United States | 32801 |
| 38 | Accelerated Enrollment Solutions (AES) | Orlando | Florida | United States | 32806 |
| 39 | Palm Beach Neurological Center | Palm Beach Gardens | Florida | United States | 33410 |
| 40 | Quantum Laboratories Inc. | Pompano Beach | Florida | United States | 33064 |
| 41 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
| 42 | Stedman Clinical Trials, LLC | Tampa | Florida | United States | 33613 |
| 43 | USF Health Byrd Institute | Tampa | Florida | United States | 33616 |
| 44 | Meridien Research | Tampa | Florida | United States | 33634 |
| 45 | Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
| 46 | Cleveland Clinic Florida - Weston | Weston | Florida | United States | 33331 |
| 47 | Emory University Cognitive Neurology Clinic & ADRC | Atlanta | Georgia | United States | 30329 |
| 48 | Medical Research Health and Education Foundation, Inc | Columbus | Georgia | United States | 31909 |
| 49 | NeuroStudies.net, LLC | Decatur | Georgia | United States | 30033 |
| 50 | Alexian Brothers Medical Center - Neuroscience Research Institute | Elk Grove Village | Illinois | United States | 60007 |
| 51 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 52 | Fort Wayne Neurological Center | Fort Wayne | Indiana | United States | 46804 |
| 53 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 54 | Josephson, Wallack, Munshower Neurology, P.C. | Indianapolis | Indiana | United States | 46256 |
| 55 | University of Kansas Medical Center Research Institute, Inc. | Fairway | Kansas | United States | 66205 |
| 56 | Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc. | Wichita | Kansas | United States | 67214 |
| 57 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 58 | McLean Hospital | Belmont | Massachusetts | United States | 02474 |
| 59 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 60 | Brigham and Women's Hospital Department of Neurology | Boston | Massachusetts | United States | 02215 |
| 61 | ActivMed Practices & Research, Inc. | Methuen | Massachusetts | United States | 01844 |
| 62 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
| 63 | Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts | United States | 02360 |
| 64 | Mayo Clinic | Rochester | Michigan | United States | 55902 |
| 65 | Hattiesburg Clinic, PA | Hattiesburg | Mississippi | United States | 39401 |
| 66 | Washington University | Saint Louis | Missouri | United States | 63108 |
| 67 | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | United States | 89106 |
| 68 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
| 69 | ActivMed Practices & Research, Inc. | Portsmouth | New Hampshire | United States | 03801 |
| 70 | Advanced Memory Research Inst. of NJ, PC | Toms River | New Jersey | United States | 08755 |
| 71 | Albany Medical College | Albany | New York | United States | 12208 |
| 72 | Empire Neurology, PC | Latham | New York | United States | 12110 |
| 73 | New York University Medical Center PRIME | New York | New York | United States | 10016 |
| 74 | Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) | New York | New York | United States | 10021 |
| 75 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 76 | University of Rochester | Rochester | New York | United States | 14620 |
| 77 | AMC Research, LLC | Charlotte | North Carolina | United States | 28270 |
| 78 | Raleigh Neurology Associates | Raleigh | North Carolina | United States | 27607-6010 |
| 79 | Gastroenterology Associates of the Piedmont | Winston-Salem | North Carolina | United States | 27103 |
| 80 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157-1207 |
| 81 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 82 | Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
| 83 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 84 | Lehigh Center for Clinical Research, LLC | Allentown | Pennsylvania | United States | 18104 |
| 85 | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 86 | Penn Memory Center | Philadelphia | Pennsylvania | United States | 19104 |
| 87 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15261 |
| 88 | Northeastern Pennsylvania Memory and Alzheimer's Center | Wilkes-Barre | Pennsylvania | United States | 18705 |
| 89 | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | United States | 02914 |
| 90 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 91 | Butler Hospital | Providence | Rhode Island | United States | 02906 |
| 92 | Roper St. Francis Healthcare | Charleston | South Carolina | United States | 29401 |
| 93 | Medical University of South Carolina (MUSC) | Charleston | South Carolina | United States | 29425 |
| 94 | Neurology Clinic, PC | Cordova | Tennessee | United States | 38018 |
| 95 | Senior Adult Specialty Research | Austin | Texas | United States | 33410 |
| 96 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390-9129 |
| 97 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 98 | Clinical Trial Network | Houston | Texas | United States | 77074 |
| 99 | University of Utah Health Sciences Center | Salt Lake City | Utah | United States | 84108 |
| 100 | The Memory Clinic | Bennington | Vermont | United States | 05201 |
| 101 | National Clinical Research Inc.-Richmond | Richmond | Virginia | United States | 23294 |
| 102 | University of Washington Medical Centre | Seattle | Washington | United States | 98104-2499 |
| 103 | Kingfisher Cooperative, LLC | Spokane | Washington | United States | 99202 |
| 104 | Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | United States | 53226 |
| 105 | The Prince Charles Hospital | Chermside | New South Wales | Australia | 4032 |
| 106 | St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
| 107 | Central Coast Neurosciences Research (Erina) | Erina | New South Wales | Australia | 2250 |
| 108 | KaRa Institute of Neurological Diseases | Macquarie Park | New South Wales | Australia | 2113 |
| 109 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 110 | Austin Health | Heidelberg West | Victoria | Australia | 3081 |
| 111 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 112 | Australian Alzheimer's Research Foundation | Nedlands | Western Australia | Australia | 6009 |
| 113 | LKH - Universitaetsklinikum Graz | Graz | Austria | 8036 | |
| 114 | Christian-Doppler-Klinik - Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
| 115 | AKH - Medizinische Universität Wien | Vienna | Austria | 1090 | |
| 116 | AZ Klina | Brasschaat | Belgium | 2930 | |
| 117 | AZ Sint-Jan | Brugge | Belgium | 8000 | |
| 118 | Universitair Ziekenhuis Brussel | Brussel | Belgium | 1090 | |
| 119 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 120 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 121 | UZ Leuven | Leuven | Belgium | 3000 | |
| 122 | AZ Delta | Roeselare | Belgium | 8800 | |
| 123 | University of Calgary - Heritage Medical Research Clinic | Calgary | Alberta | Canada | T2N4Z6 |
| 124 | The Medical Arts Health Research Group | Kamloops | British Columbia | Canada | V2C 5T1 |
| 125 | The Medical Arts Health Research Group | Penticton | British Columbia | Canada | V2A 5L5 |
| 126 | UBC Hospital | Vancouver | British Columbia | Canada | V6T 1Z3 |
| 127 | Medical Arts Health Research Group | West Vancouver | British Columbia | Canada | V7T 1C5 |
| 128 | True North Clinical Research - Halifax Inc. | Halifax | Nova Scotia | Canada | B3S 1M7 |
| 129 | True North Clinical Research | Kentville | Nova Scotia | Canada | MB3 2S7 |
| 130 | St. Joseph's HC- Parkwood Institute | London | Ontario | Canada | N6C OA7 |
| 131 | Bruyere Continuing Care | Ottawa | Ontario | Canada | K1N 5C8 |
| 132 | Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | Canada | K9H 2P4 |
| 133 | Toronto Memory Program (Neurology Research Inc.) | Toronto | Ontario | Canada | M3B 2S7 |
| 134 | Toronto Sunnybrook Hospital | Toronto | Ontario | Canada | M4N 3M5 |
| 135 | Toronto Western Hospital | Toronto | Ontario | Canada | M5T 2S8 |
| 136 | Clinique de la Memoire de l'Outaouais | Gatineau | Quebec | Canada | J8T 8J1 |
| 137 | Institut et Clinique MoCA | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 138 | Montreal Neurological Institute Clinical Research Unit | Montréal | Quebec | Canada | H3A 2B4 |
| 139 | CHU de Quebec - Hôpital de l' Enfant Jésus | Quebec | Canada | G1J 1Z4 | |
| 140 | CCBR - Ålborg - DK | Aalborg | Denmark | 9000 | |
| 141 | Danish Dementia Research Centre | København | Denmark | 2100 | |
| 142 | CCBR - Vejle - DK | Vejle | Denmark | 7100 | |
| 143 | Terveystalo Ruoholahti | Helsinki | Finland | 00180 | |
| 144 | Itä-Suomen yliopisto, Aivotutkimusyksikkö | Kuopio | Finland | 70210 | |
| 145 | CRST, Clinical Research Services Turku | Turku | Finland | 20520 | |
| 146 | CHU Strasbourg - Hôpital Hautepierre | Strasbourg Cedex | Bas Rhin | France | 67098 |
| 147 | Hôpital de la Timone | Marseille cedex 05 | Bouches-du-Rhône | France | 13385 |
| 148 | Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Bordeaux Cedex | Gironde | France | 33076 |
| 149 | Hopital Purpan | Toulouse cedex 9 | Haute Garonne | France | 31059 |
| 150 | Hôpital La Grave | Toulouse Cedex 9 | Haute Garonne | France | 31059 |
| 151 | Hopital Gui de Chauliac | Montpellier | Herault | France | 34295 |
| 152 | CHU Rennes - Pontchaillou | Rennes cedex 9 | Ille Et Vilaine | France | 35033 |
| 153 | CHU Nantes - Hopital Nord Laënnec | Nantes cedex 1 | Loire Atlantique | France | 44093 |
| 154 | CHU Reims - Hôpital Maison Blanche | Reims | Marne | France | 51092 |
| 155 | CHU Lille - Hopital Roger Salengro | Lille Cedex | Nord | France | 59037 |
| 156 | Hôpital Lariboisière | Paris cedex 10 | Paris | France | 75010 |
| 157 | CHU de Lyon - Hopital Neurologique Pierre Wertheimer | Bron Cedex | Rhone | France | 69677 |
| 158 | Hôpital des Chapennes | Villeurbanne | Rhone | France | 69100 |
| 159 | Groupe Hospitalier Pitie-Salpetriere | Paris | France | 75013 | |
| 160 | Hôpital Broca | Paris | France | 75013 | |
| 161 | Studienzentrum fur Neurologie und Psychiatrie | Böblingen | Baden Wuerttemberg | Germany | 71034 |
| 162 | ISPG - Institut fuer Studien zur Psychischen Gesundheit | Mannheim | Baden Wuerttemberg | Germany | 68165 |
| 163 | mind mvz GmbH | Stuttgart | Baden Wuerttemberg | Germany | 70182 |
| 164 | Neuropoint Studienzentrum | Ulm | Baden Wuerttemberg | Germany | 89073 |
| 165 | Universitaetsklinikum Ulm | Ulm | Baden Wuerttemberg | Germany | 89081 |
| 166 | Klinikum Bayreuth GmbH- Hohe Warte | Bayreuth | Bayern | Germany | 95445 |
| 167 | Bezirkskrankenhaus Guenzburg | Günzburg | Bayern | Germany | 89312 |
| 168 | Klinikum rechts der Isar der TU Muenchen | Munich | Bayern | Germany | 81675 |
| 169 | Institut fuer Schlaganfall- und Demenzforschung (ISD) | München | Bayern | Germany | 81377 |
| 170 | Neuropraxis Muenchen Sued | Unterhaching | Bayern | Germany | 82008 |
| 171 | Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G | Erbach | Hessen | Germany | 64711 |
| 172 | Neurologische Gemeinschaftspraxis Kassel | Kassel | Hessen | Germany | 34121 |
| 173 | Klinische Forschung Hannover-Mitte GmbH | Hannover | Niedersachsen | Germany | 30159 |
| 174 | Universitaetsklinikum Aachen AOeR | Aachen | Nordrhein Westfalen | Germany | 52074 |
| 175 | Neurozentrum Bielefeld | Bielefeld | Nordrhein Westfalen | Germany | 33647 |
| 176 | Universitaetsklinikum Duesseldorf AoeR | Duesseldorf | Nordrhein Westfalen | Germany | 40225 |
| 177 | Universitaetsklinikum Koeln | Koeln | Nordrhein Westfalen | Germany | 50937 |
| 178 | Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung | Siegen | Nordrhein Westfalen | Germany | 57076 |
| 179 | Klinikum Altenburger Land GmbH | Altenburg | Thueringen | Germany | 04600 |
| 180 | Emovis GmbH | Berlin | Germany | 10629 | |
| 181 | Neurologie im Tempelhofer Hafen | Berlin | Germany | 12099 | |
| 182 | Charite Universitaetsmedizin Berlin - Campus Berlin Buch | Berlin | Germany | 13125 | |
| 183 | Ospedale degli Infermi | Ponderano | Biella | Italy | 13875 |
| 184 | Azienda Ospedaliera Card. G. Panico | Tricase | Lecce | Italy | 73039 |
| 185 | ASST di Monza | Monza | Milano | Italy | 20052 |
| 186 | Fondazione Istituto G.Giglio di Cefalù | Cefalù | Palermo | Italy | 90015 |
| 187 | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | Italy | 25123 | |
| 188 | Azienda Ospedaliero Universitaria San Martino | Genova | Italy | 16132 | |
| 189 | Ospedale San Raffaele | Milano | Italy | 20132 | |
| 190 | Fondazione IRCCS Istituto Neurologico Carlo Besta | Milano | Italy | 20133 | |
| 191 | AOU dell'Università degli studi della Campania Luigi Vanvitelli | Napoli | Italy | 80138 | |
| 192 | Azienda Ospedaliera e Universitaria di Perugia | Perugia | Italy | 06156 | |
| 193 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56126 | |
| 194 | Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma | Italy | 00161 | |
| 195 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | 00168 | |
| 196 | Fondazione Santa Lucia IRCCS | Roma | Italy | 179 | |
| 197 | Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona | Salerno | Italy | 84131 | |
| 198 | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | Italy | 53100 | |
| 199 | Research Site | Obu-shi | Aichi-Ken | Japan | 474-8511 |
| 200 | Research Site | Chiba-shi | Chiba-Ken | Japan | 260-8656 |
| 201 | Research Site | Chiba-shi | Chiba-Ken | Japan | 263-0043 |
| 202 | Research Site | Inzai-shi | Chiba-Ken | Japan | 270-1694 |
| 203 | Research Site | Toon-shi | Ehime-Ken | Japan | 791-0295 |
| 204 | Research Site | Fukuoka-shi | Fukuoka-Ken | Japan | 814-0180 |
| 205 | Research Site | Kurume-shi | Fukuoka-Ken | Japan | 830-0011 |
| 206 | Research Site | Aizu-Wakamatsu | Fukushima-Ken | Japan | 965-8585 |
| 207 | Research Site | Otake-shi | Hiroshima-Ken | Japan | 739-0696 |
| 208 | Research Site | Asahikawa-shi | Hokkaido | Japan | 070-8644 |
| 209 | Research Site | Sapporo-shi | Hokkaido | Japan | 064-8570 |
| 210 | Research Site | Amagasaki-shi | Hyogo-Ken | Japan | 660-8511 |
| 211 | Research Site | Himeji-shi | Hyogo-Ken | Japan | 670-0981 |
| 212 | Research Site | Himeji-shi | Hyogo-Ken | Japan | 672-8043 |
| 213 | Research Site | Kobe-shi | Hyogo-Ken | Japan | 650-0047 |
| 214 | Research Site | Kita-gun | Kagawa-Ken | Japan | 761-0793 |
| 215 | Research Site | Kamakura-shi | Kanagawa-Ken | Japan | 247-8533 |
| 216 | Research Site | Kyoto-shi | Kyoto-Fu | Japan | 607-8113 |
| 217 | Research Site | Kyoto-shi | Kyoto-Fu | Japan | 616-8255 |
| 218 | Research Site | Tsu-shi | Mie-Ken | Japan | 514-8507 |
| 219 | Research Site | Togitsu | Nagasaki-Ken | Japan | 851-2103 |
| 220 | Research Site | Nagaoka-shi | Niigata-Ken | Japan | 940-2081 |
| 221 | Research Site | Yufu-shi | Oita-Ken | Japan | 879-5593 |
| 222 | Research Site | Kurashiki-shi | Okayama-Ken | Japan | 247-8533 |
| 223 | Research Site | Okayama-shi | Okayama-Ken | Japan | 703-8265 |
| 224 | Research Site | Tsukuba | Okayama-Ken | Japan | 701-0304 |
| 225 | Research Site | Osaka-shi | Osaka-Fu | Japan | 545-8586 |
| 226 | Research Site | Suita-shi | Osaka-Fu | Japan | 565-0871 |
| 227 | Research Site | Iruma-gun | Saitama-Ken | Japan | 350-0495 |
| 228 | Research Site | Kasukabe-shi | Saitama-Ken | Japan | 344-0036 |
| 229 | Research Site | Shizuka-shi | Shizuoka-Ken | Japan | 424-8636 |
| 230 | Research Site | Shizuoka-shi | Shizuoka-Ken | Japan | 420-8688 |
| 231 | Research Site | Bunkyo-ku | Tokyo-To | Japan | 113-0034 |
| 232 | Research Site | Kiyose-shi | Tokyo-To | Japan | 204-8585 |
| 233 | Research Site | Kodaira-shi | Tokyo-To | Japan | 187-8551 |
| 234 | Research Site | Yamagata-shi | Yamagata-Ken | Japan | 990-0834 |
| 235 | Inha University Hospital | Incheon | Gyeonggi-do | Korea, Republic of | 22332 |
| 236 | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do | Korea, Republic of | 13620 |
| 237 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 405-760 | |
| 238 | Konkuk University Medical Center | Seoul | Korea, Republic of | 05030 | |
| 239 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 240 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
| 241 | Brain Research Center | Amsterdam | Netherlands | 1081 GN | |
| 242 | Amphia Ziekenhuis, Molengracht | Breda | Netherlands | 4818 CK | |
| 243 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3015 AA | |
| 244 | Podlaskie Centrum Psychogeriatrii | Bialystok | Poland | 15-756 | |
| 245 | PALLMED Sp. z o.o. | Bydgoszcz | Poland | 85-023 | |
| 246 | Klinika Psychiatrii Doroslych UCK | Gdansk | Poland | 80-952 | |
| 247 | Novo-Med Zielinski i wspolnicy Sp. j. | Katowice | Poland | 40-650 | |
| 248 | SPZOZ Centralny Szpital Kliniczny UM w Lodzi | Lodz | Poland | 92-216 | |
| 249 | Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland | 20-954 | |
| 250 | NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek. | Poznan | Poland | 61-853 | |
| 251 | Neuro-Care Gabriela Klodowska | Siemianowice Slaskie | Poland | 41-100 | |
| 252 | Centrum Medyczne Senior | Sopot | Poland | 81-855 | |
| 253 | Osrodek Badan Klinicznych EUROMEDIS | Szczecin | Poland | 70-111 | |
| 254 | Centrum Medyczne NeuroProtect | Warszawa | Poland | 01-684 | |
| 255 | NZOZ Wroclawskie Centrum Alzheimerowskie | Wroclaw | Poland | 53659 | |
| 256 | Hospital de Braga | Braga | Portugal | 4710-243 | |
| 257 | Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra | Coimbra | Portugal | 3040-278 | |
| 258 | Hospital Beatriz Ângelo | Loures | Portugal | 2674-514 | |
| 259 | CNS-Campus Neurologico Senior | Torres Vedras | Portugal | 2560-280 | |
| 260 | Hospital General Universitario de Elche | Elche | Alicante | Spain | 03203 |
| 261 | Hospital Universitario Reina Sofia | Cordoba | Córdoba | Spain | 14011 |
| 262 | Policlinica Gipuzkoa | San Sebastian | Guipuzcoa | Spain | 20009 |
| 263 | Clinica Universidad de Navarra | Pamplona | Navarra | Spain | 31008 |
| 264 | CAE Oroitu | Getxo | Vizcaya | Spain | 48993 |
| 265 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 266 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
| 267 | Fundacio ACE | Barcelona | Spain | 08028 | |
| 268 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
| 269 | Hospital Universitari de Santa Maria | Lleida | Spain | 25198 | |
| 270 | Complejo Hospitalario Ruber Juan Bravo | Madrid | Spain | 28006 | |
| 271 | Hospital Victoria Eugenia | Sevilla | Spain | 41009 | |
| 272 | Hospital Universitario Dr. Peset | Valencia | Spain | 46017 | |
| 273 | Hospital Universitari i Politecnic La Fe | Valencia | Spain | 46026 | |
| 274 | Skånes Universitetssjukhus | Malmö | Sweden | 205 02 | |
| 275 | Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus | Mölndal | Sweden | 205 02 | |
| 276 | Karolinska Universitetssjukhuset, Huddinge | Stockholm | Sweden | 141 86 | |
| 277 | Akademiska Sjukhuset | Uppsala | Sweden | 75185 | |
| 278 | Spitalzentrum Biel | Biel/Bienne | Switzerland | 2501 | |
| 279 | Hôpitaux Universitaires de Geneve- HUG | Genève | Switzerland | 1205 | |
| 280 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | 1011 | |
| 281 | Ospedale Regionale di Lugano | Lugano | Switzerland | 6900 | |
| 282 | Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren | Schlieren | Switzerland | 8952 | |
| 283 | Changhua Christian Medical Foundation Changhua Christian Hospital | Changhua | Taiwan | 50004 | |
| 284 | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | Taiwan | 833 | |
| 285 | National Cheng Kung University Hospital | Tainan | Taiwan | 704 | |
| 286 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
| 287 | Chang Gung Memorial Hospital, Linkou | Taoyuan City | Taiwan | 333 | |
| 288 | Re:Cognition Health Ltd (London) | London | Greater London | United Kingdom | W1G 9JF |
| 289 | Charing Cross Hospital | London | Greater London | United Kingdom | W6 8RF |
| 290 | The National Hospital for Neurology and Neurosurgery Centre | London | Greater London | United Kingdom | WC1N 3BG |
| 291 | Manchester Royal Infirmary | Manchester | Greater Manchester | United Kingdom | M13 9WL |
| 292 | The University of Edinburgh | Edinburgh | Lothian Region | United Kingdom | EH10 5HF |
| 293 | The RICE Centre | Bath | Somerset | United Kingdom | BA1 3NG |
| 294 | Queen Elizabeth University Hospital Campus | Glasgow | Strathclyde | United Kingdom | G21 3UW |
| 295 | Glasgow Memory Clinic Ltd | Motherwell | Strathclyde | United Kingdom | ML1 4UF |
| 296 | Ninewells Hospital | Dundee | Tayside Region | United Kingdom | DD1 9SY |
| 297 | Newcastle University | Newcastle upon Tyne | Tyne & Wear | United Kingdom | NE4 5PL |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT04241068
Other Study ID Numbers:
- 221AD304
- 2019-004368-22
First Posted:
Jan 27, 2020
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: