Multiple Sclerosis Clinical Trial
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
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).
Eligibility Criteria
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.
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There are 287 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85013, United States
Sun City Arizona, 85351, United States
Tucson Arizona, 85718, United States
Fullerton California, 92835, United States
Irvine California, 92607, United States
La Jolla California, 92037, United States
Laguna Hills California, 92653, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Oxnard California, 93030, United States
Palo Alto California, 94304, United States
Redlands California, 92374, United States
San Diego California, 92103, United States
San Francisco California, 94143, United States
Santa Ana California, 92705, United States
Sherman Oaks California, 91403, United States
Aurora Colorado, 80045, United States
Centennial Colorado, 80112, United States
Fairfield Connecticut, 06824, United States
New Haven Connecticut, 06510, United States
New Haven Connecticut, 06510, United States
Norwalk Connecticut, 06851, United States
Washington District of Columbia, 20007, United States
Atlantis Florida, 33462, United States
Bradenton Florida, 34205, United States
Delray Beach Florida, 33440, United States
Fort Myers Florida, 33912, United States
Hollywood Florida, 33024, United States
Jacksonville Florida, 32216, United States
Jacksonville Florida, 33462, United States
Miami Florida, 33136, United States
Miami Florida, 33180, United States
Ocala Florida, 34470, United States
Orlando Florida, 32162, United States
Orlando Florida, 32801, United States
Orlando Florida, 32806, United States
Palm Beach Gardens Florida, 33410, United States
Pompano Beach Florida, 33064, United States
Tampa Florida, 33609, United States
Tampa Florida, 33613, United States
Tampa Florida, 33616, United States
Tampa Florida, 33634, United States
West Palm Beach Florida, 33407, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30329, United States
Columbus Georgia, 31909, United States
Decatur Georgia, 30033, United States
Elk Grove Village Illinois, 60007, United States
Park Ridge Illinois, 60068, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46256, United States
Fairway Kansas, 66205, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40503, United States
Belmont Massachusetts, 02474, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Methuen Massachusetts, 01844, United States
Newton Massachusetts, 02459, United States
Plymouth Massachusetts, 02360, United States
Rochester Michigan, 55902, United States
Hattiesburg Mississippi, 39401, United States
Saint Louis Missouri, 63108, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89113, United States
Portsmouth New Hampshire, 03801, United States
Toms River New Jersey, 08755, United States
Albany New York, 12208, United States
Latham New York, 12110, United States
New York New York, 10016, United States
New York New York, 10021, United States
New York New York, 10029, United States
Rochester New York, 14620, United States
Charlotte North Carolina, 28270, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73112, United States
Allentown Pennsylvania, 18104, United States
Jenkintown Pennsylvania, 19046, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15261, United States
Wilkes-Barre Pennsylvania, 18705, United States
East Providence Rhode Island, 02914, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02906, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Cordova Tennessee, 38018, United States
Austin Texas, 33410, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77074, United States
Salt Lake City Utah, 84108, United States
Bennington Vermont, 05201, United States
Richmond Virginia, 23294, United States
Seattle Washington, 98104, United States
Spokane Washington, 99202, United States
Milwaukee Wisconsin, 53226, United States
Chermside New South Wales, 4032, Australia
Darlinghurst New South Wales, 2010, Australia
Erina New South Wales, 2250, Australia
Macquarie Park New South Wales, 2113, Australia
Box Hill Victoria, 3128, Australia
Heidelberg West Victoria, 3081, Australia
Parkville Victoria, 3050, Australia
Nedlands Western Australia, 6009, Australia
Graz , 8036, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Brasschaat , 2930, Belgium
Brugge , 8000, Belgium
Brussel , 1090, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Roeselare , 8800, Belgium
Calgary Alberta, T2N4Z, Canada
Kamloops British Columbia, V2C 5, Canada
Penticton British Columbia, V2A 5, Canada
Vancouver British Columbia, V6T 1, Canada
West Vancouver British Columbia, V7T 1, Canada
Halifax Nova Scotia, B3S 1, Canada
Kentville Nova Scotia, MB3 2, Canada
London Ontario, N6C O, Canada
Ottawa Ontario, K1N 5, Canada
Peterborough Ontario, K9H 2, Canada
Toronto Ontario, M3B 2, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5T 2, Canada
Gatineau Quebec, J8T 8, Canada
Greenfield Park Quebec, J4V 2, Canada
Montréal Quebec, H3A 2, Canada
Quebec , G1J 1, Canada
Aalborg , 9000, Denmark
København , 2100, Denmark
Vejle , 7100, Denmark
Helsinki , 00180, Finland
Kuopio , 70210, Finland
Turku , 20520, Finland
Strasbourg Cedex Bas Rhin, 67098, France
Marseille cedex 05 Bouches-du-Rhône, 13385, France
Bordeaux Cedex Gironde, 33076, France
Toulouse cedex 9 Haute Garonne, 31059, France
Toulouse Cedex 9 Haute Garonne, 31059, France
Montpellier Herault, 34295, France
Rennes cedex 9 Ille Et Vilaine, 35033, France
Nantes cedex 1 Loire Atlantique, 44093, France
Reims Marne, 51092, France
Lille Cedex Nord, 59037, France
Paris cedex 10 Paris, 75010, France
Bron Cedex Rhone, 69677, France
Villeurbanne Rhone, 69100, France
Paris , 75013, France
Paris , 75013, France
Böblingen Baden Wuerttemberg, 71034, Germany
Mannheim Baden Wuerttemberg, 68165, Germany
Stuttgart Baden Wuerttemberg, 70182, Germany
Ulm Baden Wuerttemberg, 89073, Germany
Ulm Baden Wuerttemberg, 89081, Germany
Bayreuth Bayern, 95445, Germany
Günzburg Bayern, 89312, Germany
Munich Bayern, 81675, Germany
München Bayern, 81377, Germany
Unterhaching Bayern, 82008, Germany
Erbach Hessen, 64711, Germany
Kassel Hessen, 34121, Germany
Hannover Niedersachsen, 30159, Germany
Aachen Nordrhein Westfalen, 52074, Germany
Bielefeld Nordrhein Westfalen, 33647, Germany
Duesseldorf Nordrhein Westfalen, 40225, Germany
Koeln Nordrhein Westfalen, 50937, Germany
Siegen Nordrhein Westfalen, 57076, Germany
Altenburg Thueringen, 04600, Germany
Berlin , 10629, Germany
Berlin , 12099, Germany
Berlin , 13125, Germany
Ponderano Biella, 13875, Italy
Tricase Lecce, 73039, Italy
Monza Milano, 20052, Italy
Cefalù Palermo, 90015, Italy
Brescia , 25123, Italy
Genova , 16132, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Napoli , 80138, Italy
Perugia , 06156, Italy
Pisa , 56126, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Roma , 179, Italy
Salerno , 84131, Italy
Siena , 53100, Italy
Obu-shi Aichi-Ken, 474-8, Japan
Chiba-shi Chiba-Ken, 260-8, Japan
Chiba-shi Chiba-Ken, 263-0, Japan
Inzai-shi Chiba-Ken, 270-1, Japan
Toon-shi Ehime-Ken, 791-0, Japan
Fukuoka-shi Fukuoka-Ken, 814-0, Japan
Kurume-shi Fukuoka-Ken, 830-0, Japan
Aizu-Wakamatsu Fukushima-Ken, 965-8, Japan
Otake-shi Hiroshima-Ken, 739-0, Japan
Asahikawa-shi Hokkaido, 070-8, Japan
Sapporo-shi Hokkaido, 064-8, Japan
Amagasaki-shi Hyogo-Ken, 660-8, Japan
Himeji-shi Hyogo-Ken, 670-0, Japan
Himeji-shi Hyogo-Ken, 672-8, Japan
Kobe-shi Hyogo-Ken, 650-0, Japan
Kita-gun Kagawa-Ken, 761-0, Japan
Kamakura-shi Kanagawa-Ken, 247-8, Japan
Kyoto-shi Kyoto-Fu, 607-8, Japan
Kyoto-shi Kyoto-Fu, 616-8, Japan
Tsu-shi Mie-Ken, 514-8, Japan
Togitsu Nagasaki-Ken, 851-2, Japan
Nagaoka-shi Niigata-Ken, 940-2, Japan
Yufu-shi Oita-Ken, 879-5, Japan
Kurashiki-shi Okayama-Ken, 247-8, Japan
Okayama-shi Okayama-Ken, 703-8, Japan
Tsukuba Okayama-Ken, 701-0, Japan
Osaka-shi Osaka-Fu, 545-8, Japan
Suita-shi Osaka-Fu, 565-0, Japan
Iruma-gun Saitama-Ken, 350-0, Japan
Kasukabe-shi Saitama-Ken, 344-0, Japan
Shizuka-shi Shizuoka-Ken, 424-8, Japan
Shizuoka-shi Shizuoka-Ken, 420-8, Japan
Bunkyo-ku Tokyo-To, 113-0, Japan
Kiyose-shi Tokyo-To, 204-8, Japan
Kodaira-shi Tokyo-To, 187-8, Japan
Yamagata-shi Yamagata-Ken, 990-0, Japan
Incheon Gyeonggi-do, 22332, Korea, Republic of
Seongnam Gyeonggi-do, 13620, Korea, Republic of
Incheon , 405-7, Korea, Republic of
Seoul , 05030, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Rotterdam , 3015 , Netherlands
Bialystok , 15-75, Poland
Bydgoszcz , 85-02, Poland
Gdansk , 80-95, Poland
Katowice , 40-65, Poland
Lodz , 92-21, Poland
Lublin , 20-95, Poland
Poznan , 61-85, Poland
Siemianowice Slaskie , 41-10, Poland
Sopot , 81-85, Poland
Szczecin , 70-11, Poland
Warszawa , 01-68, Poland
Wroclaw , 53659, Poland
Braga , 4710-, Portugal
Coimbra , 3040-, Portugal
Loures , 2674-, Portugal
Torres Vedras , 2560-, Portugal
Elche Alicante, 03203, Spain
Cordoba Córdoba, 14011, Spain
San Sebastian Guipuzcoa, 20009, Spain
Pamplona Navarra, 31008, Spain
Getxo Vizcaya, 48993, Spain
Barcelona , 08003, Spain
Barcelona , 08025, Spain
Barcelona , 08028, Spain
Barcelona , 08036, Spain
Lleida , 25198, Spain
Madrid , 28006, Spain
Sevilla , 41009, Spain
Valencia , 46017, Spain
Valencia , 46026, Spain
Malmö , 205 0, Sweden
Mölndal , 205 0, Sweden
Stockholm , 141 8, Sweden
Uppsala , 75185, Sweden
Biel/Bienne , 2501, Switzerland
Genève , 1205, Switzerland
Lausanne , 1011, Switzerland
Lugano , 6900, Switzerland
Schlieren , 8952, Switzerland
Changhua , 50004, Taiwan
Kaohsiung , 833, Taiwan
Tainan , 704, Taiwan
Taipei , 11217, Taiwan
Taoyuan City , 333, Taiwan
London Greater London, W1G 9, United Kingdom
London Greater London, W6 8R, United Kingdom
London Greater London, WC1N , United Kingdom
Manchester Greater Manchester, M13 9, United Kingdom
Edinburgh Lothian Region, EH10 , United Kingdom
Bath Somerset, BA1 3, United Kingdom
Glasgow Strathclyde, G21 3, United Kingdom
Motherwell Strathclyde, ML1 4, United Kingdom
Dundee Tayside Region, DD1 9, United Kingdom
Newcastle upon Tyne Tyne & Wear, NE4 5, United Kingdom
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