TANGO: Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Study Details
Study Description
Brief Summary
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.
The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Low-dose BIIB092 Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind. |
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
|
Experimental: Medium-dose BIIB092 Intravenous (IV) infusion once every 4 weeks. |
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
|
Experimental: High-dose BIIB092 Intravenous (IV) infusion once every 4 weeks. |
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
|
Placebo Comparator: Placebo Intravenous (IV) infusion once every 4 weeks. |
Drug: Placebo
Administered as specified in treatment arm.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Week 238]
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Secondary Outcome Measures
- Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [From Baseline to Week 78]
The CDR-SB is a validated clinical assessment of global function in participants with AD. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB which ranges from 0 to 18 (severe impairment).
- Percentage of Participants With Anti-BIIB092 Antibodies in Serum Over Time up to Week 90 [From Baseline up to Week 90]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Must have a gradual and progressive change in memory function over more than 6 months.
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Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
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Objective evidence of cognitive impairment at Screening
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Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
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Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
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CDR Memory Box score of ≥0.5
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Must consent to apolipoprotein E (ApoE) genotyping
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Must have 1 informant/study partner
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Must have amyloid beta positivity confirmed at Screening
Key Exclusion Criteria:
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Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
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Clinically significant, unstable psychiatric illness
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Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
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Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
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History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
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Indication of impaired renal or liver function
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Alcohol or substance abuse in past 1 year
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Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
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Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
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Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
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Contraindications to study procedures
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35205 |
2 | Xenoscience Inc | Phoenix | Arizona | United States | 85004 |
3 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
4 | Dignity Health | Phoenix | Arizona | United States | 85013 |
5 | Banner Sun Health Research Institute | Sun City | Arizona | United States | 85351 |
6 | Advanced Research Center, Inc. | Anaheim | California | United States | 92805 |
7 | The Research Center of Southern California | Carlsbad | California | United States | 92011 |
8 | Positron Research International | Fremont | California | United States | 94538 |
9 | Neuropain Medical Center | Fresno | California | United States | 93710 |
10 | V Royter, MD, APMC | Hanford | California | United States | 93230 |
11 | Irvine Center for Clinical Research, Inc. | Irvine | California | United States | 92614 |
12 | Research Center for Clinical Studies West | Lancaster | California | United States | 93534 |
13 | Mary S. Easton Center for Alzheimer's Disease Research, UCLA | Los Angeles | California | United States | 90095 |
14 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
15 | Stanford Hospital and Clinics | Palo Alto | California | United States | 94304 |
16 | Pacific Research Network, Inc | San Diego | California | United States | 92103 |
17 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
18 | Invicro | New Haven | Connecticut | United States | 06510 |
19 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06520 |
20 | JEM Research Institute | Atlantis | Florida | United States | 33462 |
21 | Brain Matters Research | Delray Beach | Florida | United States | 33445 |
22 | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | United States | 33912 |
23 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
24 | Synexus Clinical Research US, Inc. - Orlando | Orlando | Florida | United States | 32806 |
25 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
26 | Brain Matters Research | Stuart | Florida | United States | 34997 |
27 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
28 | Olympian Clinical Research | Tampa | Florida | United States | 33614 |
29 | Synexus Clinical Research US, Inc. - The Villages | The Villages | Florida | United States | 32162 |
30 | Emory University Cognitive Neurology Clinic & ADRC | Atlanta | Georgia | United States | 30329 |
31 | McLean Hospital | Belmont | Massachusetts | United States | 02478 |
32 | Tufts | Boston | Massachusetts | United States | 02111 |
33 | Brigham and Women's Hospital Department of Neurology | Boston | Massachusetts | United States | 02115 5804 |
34 | ActivMed Practices & Research | Methuen | Massachusetts | United States | 01844 |
35 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
36 | Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts | United States | 02360 |
37 | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | United States | 89106 |
38 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
39 | The Cognitive Research Center of New Jersey | Springfield | New Jersey | United States | 07081 |
40 | Advanced Memory Enhancement Center of NJ | Toms River | New Jersey | United States | 08755 |
41 | New York University Medical Center PRIME | New York | New York | United States | 10016 |
42 | AD-CARE, University of Rochester | Rochester | New York | United States | 14620 |
43 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
44 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
45 | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | United States | 02915 |
46 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
47 | Butler Hospital | Providence | Rhode Island | United States | 02906 |
48 | Neurology Clinic, PC | Cordova | Tennessee | United States | 38018 |
49 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
50 | The Methodist Hospital | Houston | Texas | United States | 77030 |
51 | The Memory Clinic, Inc. | Bennington | Vermont | United States | 05201 |
52 | Cognition Health | Fairfax | Virginia | United States | 22031 |
53 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
54 | Caulfield Hospital | Caulfield | Victoria | Australia | 3162 |
55 | Austin Hospital | Heidelberg West | Victoria | Australia | 3081 |
56 | Royal Melbourne Hospital | Melbourne | Victoria | Australia | 3000 |
57 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
58 | CHU Strasbourg - Hôpital Hautepierre | Strasbourg Cedex | Bas Rhin | France | 67098 |
59 | Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Bordeaux Cedex | Gironde | France | 33076 |
60 | Hôpital La Grave | Toulouse Cedex 9 | Haute Garonne | France | 31059 |
61 | Hopital Gui de Chauliac | Montpellier | Herault | France | 34295 |
62 | CHU Rennes - Pontchaillou | Rennes cedex 2 | Ille Et Vilaine | France | 35033 |
63 | CHU Nantes - Hopital Nord Laënnec | Nantes cedex 1 | Loire Atlantique | France | 44093 |
64 | Hôpital Lariboisière | Paris cedex 10 | Paris | France | 75010 |
65 | Hôpital des Chapennes | Villeurbanne | Rhone | France | 69100 |
66 | Groupe Hospitalier Pitie-Salpetriere | Paris | France | 75013 | |
67 | Studienzentrum fur Neurologie und Psychiatrie | Böblingen | Baden Wuertemberg | Germany | 71034 |
68 | ISPG - Institut fuer Studien zur Psychischen Gesundheit | Mannheim | Baden Wuerttemberg | Germany | 68165 |
69 | Universitaetsklinikum Ulm | Ulm | Baden Wuerttemberg | Germany | 89081 |
70 | Institut fuer Schlaganfall- und Demenzforschung (ISD) | Muenchen | Bayern | Germany | 81377 |
71 | Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | Hessen | Germany | 60528 |
72 | Universitaetsklinikum Bonn AoeR | Bonn | Nordrhein Westfalen | Germany | 53105 |
73 | Klinikum Altenburger Land GmbH | Altenburg | Thueringen | Germany | 04600 |
74 | Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC) | Berlin | Germany | 13125 | |
75 | IRCCS Centro San Giovanni di Dio Fatebenefratelli | Brescia | Italy | 25125 | |
76 | Ospedale San Raffaele | Milano | Italy | 20132 | |
77 | Azienda Ospedaliero Universitaria Policlinico Paolo | Palermo | Italy | 90127 | |
78 | Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma | Italy | 00185 | |
79 | ULSS 6 Vicenza | Vicenza | Italy | 36100 | |
80 | Research Site | Obu-shi | Aichi-Ken | Japan | 474-8511 |
81 | Research Site | Chiba-shi | Chiba-Ken | Japan | 263-0043 |
82 | Research Site | Kawasaki-shi | Kanagawa-Ken | Japan | 213-8507 |
83 | Research Site | Kyoto-shi | Kyoto-Fu | Japan | 600-8558 |
84 | Research Site | Kurashiki-shi | Okayama-Ken | Japan | 710-0813 |
85 | Research Site | Suita-shi | Osaka-Fu | Japan | 565-0871 |
86 | PALLMED Sp. z o.o. | Bydgoszcz | Poland | 85-023 | |
87 | Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland | 20-954 | |
88 | Centrum Medyczne Senior | Sopot | Poland | 81-855 | |
89 | Centrum Medyczne NeuroProtect | Warszawa | Poland | 01-697 | |
90 | Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo | Warszawa | Poland | 03-242 | |
91 | CAE Oroitu | Getxo | Vizcaya | Spain | 48993 |
92 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
93 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
94 | Fundacio ACE | Barcelona | Spain | 8028 | |
95 | Hospital de Santa Maria | Lleida | Spain | 25198 | |
96 | Complejo Hospitalario Ruber Juan Bravo | Madrid | Spain | 28006 | |
97 | Hospital Victoria Eugenia | Sevilla | Spain | 41009 | |
98 | Hospital Universitari i Politecnic La Fe | Valencia | Spain | 46026 | |
99 | Skånes Universitetssjukhus | Malmo | Sweden | 212 24 | |
100 | Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus | Molndal | Sweden | 43180 | |
101 | Karolinska Universitetssjukhuset, Huddinge | Stockholm | Sweden | 141 86 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 251AD201
- 2017-002901-37