search
Back to results

Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease (TANGO)

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB092
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Mild cognitive impairment, Alzheimer's disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Must have a gradual and progressive change in memory function over more than 6 months.
  • Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
  • Objective evidence of cognitive impairment at Screening
  • Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
  • Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
  • CDR Memory Box score of ≥0.5
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have 1 informant/study partner
  • Must have amyloid beta positivity confirmed at Screening

Key Exclusion Criteria:

  • 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
  • Clinically significant, unstable psychiatric illness
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
  • Indication of impaired renal or liver function
  • Alcohol or substance abuse in past 1 year
  • Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
  • 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.
  • 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.
  • Contraindications to study procedures

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • University of Alabama at Birmingham
  • Xenoscience Inc
  • Banner Alzheimer's Institute
  • Dignity Health
  • Banner Sun Health Research Institute
  • Advanced Research Center, Inc.
  • The Research Center of Southern California
  • Positron Research International
  • Neuropain Medical Center
  • V Royter, MD, APMC
  • Irvine Center for Clinical Research, Inc.
  • Research Center for Clinical Studies West
  • Mary S. Easton Center for Alzheimer's Disease Research, UCLA
  • Hoag Memorial Hospital Presbyterian
  • Stanford Hospital and Clinics
  • Pacific Research Network, Inc
  • Syrentis Clinical Research
  • Invicro
  • Yale University School Of Medicine
  • JEM Research Institute
  • Brain Matters Research
  • Neuropsychiatric Research Center of Southwest Florida
  • Renstar Medical Research
  • Synexus Clinical Research US, Inc. - Orlando
  • Progressive Medical Research
  • Brain Matters Research
  • Axiom Clinical Research of Florida
  • Olympian Clinical Research
  • Synexus Clinical Research US, Inc. - The Villages
  • Emory University Cognitive Neurology Clinic & ADRC
  • McLean Hospital
  • Tufts
  • Brigham and Women's Hospital Department of Neurology
  • ActivMed Practices & Research
  • Boston Center for Memory
  • Donald S. Marks, M.D., P.C.
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • Las Vegas Medical Research
  • The Cognitive Research Center of New Jersey
  • Advanced Memory Enhancement Center of NJ
  • New York University Medical Center PRIME
  • AD-CARE, University of Rochester
  • Richmond Behavioral Associates
  • Cleveland Clinic
  • Rhode Island Mood & Memory Research Institute
  • Rhode Island Hospital
  • Butler Hospital
  • Neurology Clinic, PC
  • Baylor College of Medicine
  • The Methodist Hospital
  • The Memory Clinic, Inc.
  • Cognition Health
  • Box Hill Hospital
  • Caulfield Hospital
  • Austin Hospital
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • CHU Strasbourg - Hôpital Hautepierre
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Hôpital La Grave
  • Hopital Gui de Chauliac
  • CHU Rennes - Pontchaillou
  • CHU Nantes - Hopital Nord Laënnec
  • Hôpital Lariboisière
  • Hôpital des Chapennes
  • Groupe Hospitalier Pitie-Salpetriere
  • Studienzentrum fur Neurologie und Psychiatrie
  • ISPG - Institut fuer Studien zur Psychischen Gesundheit
  • Universitaetsklinikum Ulm
  • Institut fuer Schlaganfall- und Demenzforschung (ISD)
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Bonn AoeR
  • Klinikum Altenburger Land GmbH
  • Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
  • IRCCS Centro San Giovanni di Dio Fatebenefratelli
  • Ospedale San Raffaele
  • Azienda Ospedaliero Universitaria Policlinico Paolo
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • ULSS 6 Vicenza
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • PALLMED Sp. z o.o.
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Centrum Medyczne Senior
  • Centrum Medyczne NeuroProtect
  • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
  • CAE Oroitu
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic de Barcelona
  • Fundacio ACE
  • Hospital de Santa Maria
  • Complejo Hospitalario Ruber Juan Bravo
  • Hospital Victoria Eugenia
  • Hospital Universitari i Politecnic La Fe
  • Skånes Universitetssjukhus
  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
  • Karolinska Universitetssjukhuset, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low-dose BIIB092

Medium-dose BIIB092

High-dose BIIB092

Placebo

Arm Description

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.

Intravenous (IV) infusion once every 4 weeks.

Intravenous (IV) infusion once every 4 weeks.

Intravenous (IV) infusion once every 4 weeks.

Outcomes

Primary Outcome Measures

PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
LTE Period: Percentage of Participants With AEs and SAEs
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. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.

Secondary Outcome Measures

PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. 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 score which ranges from 0 (none) to 18 (severe impairment).
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum

Full Information

First Posted
November 21, 2017
Last Updated
October 18, 2022
Sponsor
Biogen
search

1. Study Identification

Unique Protocol Identification Number
NCT03352557
Brief Title
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Acronym
TANGO
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Mild cognitive impairment, Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose BIIB092
Arm Type
Experimental
Arm Description
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.
Arm Title
Medium-dose BIIB092
Arm Type
Experimental
Arm Description
Intravenous (IV) infusion once every 4 weeks.
Arm Title
High-dose BIIB092
Arm Type
Experimental
Arm Description
Intravenous (IV) infusion once every 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous (IV) infusion once every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
BIIB092
Other Intervention Name(s)
Formally known as BMS 986168
Intervention Description
Administered as specified in treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in treatment arm.
Primary Outcome Measure Information:
Title
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Time Frame
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
Title
LTE Period: Percentage of Participants With AEs and SAEs
Description
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. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Time Frame
From Week 80 to Week 173
Secondary Outcome Measure Information:
Title
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
Description
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. 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 score which ranges from 0 (none) to 18 (severe impairment).
Time Frame
Baseline, Week 78
Title
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
Time Frame
Baseline up to Week 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have a gradual and progressive change in memory function over more than 6 months. Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have Objective evidence of cognitive impairment at Screening Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive) CDR Memory Box score of ≥0.5 Must consent to apolipoprotein E (ApoE) genotyping Must have 1 informant/study partner Must have amyloid beta positivity confirmed at Screening Key Exclusion Criteria: 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 Clinically significant, unstable psychiatric illness Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1 Indication of impaired renal or liver function Alcohol or substance abuse in past 1 year Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period 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. 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. Contraindications to study procedures NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Xenoscience Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Dignity Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
The Research Center of Southern California
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Positron Research International
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Neuropain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
V Royter, MD, APMC
City
Hanford
State/Province
California
ZIP/Postal Code
93230
Country
United States
Facility Name
Irvine Center for Clinical Research, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Research Center for Clinical Studies West
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Pacific Research Network, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Invicro
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - The Villages
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Emory University Cognitive Neurology Clinic & ADRC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Tufts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital Department of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115 5804
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Donald S. Marks, M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
The Cognitive Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Enhancement Center of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
New York University Medical Center PRIME
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
AD-CARE, University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Memory Clinic, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Cognition Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Caulfield Hospital
City
Caulfield
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
CHU Strasbourg - Hôpital Hautepierre
City
Strasbourg Cedex
State/Province
Bas Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
City
Bordeaux Cedex
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital La Grave
City
Toulouse Cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Gui de Chauliac
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Rennes - Pontchaillou
City
Rennes cedex 2
State/Province
Ille Et Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Nantes - Hopital Nord Laënnec
City
Nantes cedex 1
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Lariboisière
City
Paris cedex 10
State/Province
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital des Chapennes
City
Villeurbanne
State/Province
Rhone
ZIP/Postal Code
69100
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Studienzentrum fur Neurologie und Psychiatrie
City
Böblingen
State/Province
Baden Wuertemberg
ZIP/Postal Code
71034
Country
Germany
Facility Name
ISPG - Institut fuer Studien zur Psychischen Gesundheit
City
Mannheim
State/Province
Baden Wuerttemberg
ZIP/Postal Code
68165
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Institut fuer Schlaganfall- und Demenzforschung (ISD)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitaetsklinikum Bonn AoeR
City
Bonn
State/Province
Nordrhein Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Altenburger Land GmbH
City
Altenburg
State/Province
Thueringen
ZIP/Postal Code
04600
Country
Germany
Facility Name
Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
IRCCS Centro San Giovanni di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
ULSS 6 Vicenza
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Research Site
City
Obu-shi
State/Province
Aichi-Ken
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Research Site
City
Chiba-shi
State/Province
Chiba-Ken
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
600-8558
Country
Japan
Facility Name
Research Site
City
Kurashiki-shi
State/Province
Okayama-Ken
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Research Site
City
Suita-shi
State/Province
Osaka-Fu
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
PALLMED Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-023
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Centrum Medyczne Senior
City
Sopot
ZIP/Postal Code
81-855
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
CAE Oroitu
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Fundacio ACE
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
Hospital de Santa Maria
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Complejo Hospitalario Ruber Juan Bravo
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Victoria Eugenia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Skånes Universitetssjukhus
City
Malmo
ZIP/Postal Code
212 24
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
City
Molndal
ZIP/Postal Code
43180
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
IPD Sharing URL
https://vivli.org/

Learn more about this trial

Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

We'll reach out to this number within 24 hrs