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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03352557




Registration number
NCT03352557
Ethics application status
Date submitted
21/11/2017
Date registered
24/11/2017

Titles & IDs
Public title
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
2017-002901-37
Secondary ID [2] 0 0
251AD201
Universal Trial Number (UTN)
Trial acronym
TANGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB092
Treatment: Drugs - Placebo

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.

Experimental: Medium-dose BIIB092 - Intravenous (IV) infusion once every 4 weeks.

Experimental: High-dose BIIB092 - Intravenous (IV) infusion once every 4 weeks.

Placebo comparator: Placebo - Intravenous (IV) infusion once every 4 weeks.


Treatment: Drugs: BIIB092
Administered as specified in treatment arm.

Treatment: Drugs: Placebo
Administered as specified in treatment arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
Primary outcome [2] 0 0
LTE Period: Percentage of Participants With AEs and SAEs
Timepoint [2] 0 0
From Week 80 to Week 173
Secondary outcome [1] 0 0
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
Timepoint [1] 0 0
Baseline, Week 78
Secondary outcome [2] 0 0
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
Timepoint [2] 0 0
Baseline up to Week 76

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2021
Sample size
Target
Accrual to date
Final
654
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 0 0
Caulfield Hospital - Caulfield
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg West
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Rhode Island
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
France
State/province [17] 0 0
Bas Rhin
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France
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Gironde
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France
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Haute Garonne
Country [20] 0 0
France
State/province [20] 0 0
Herault
Country [21] 0 0
France
State/province [21] 0 0
Ille Et Vilaine
Country [22] 0 0
France
State/province [22] 0 0
Loire Atlantique
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Rhone
Country [25] 0 0
Germany
State/province [25] 0 0
Baden Wuertemberg
Country [26] 0 0
Germany
State/province [26] 0 0
Baden Wuerttemberg
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Germany
State/province [27] 0 0
Bayern
Country [28] 0 0
Germany
State/province [28] 0 0
Hessen
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein Westfalen
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Germany
State/province [30] 0 0
Thueringen
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Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Italy
State/province [32] 0 0
Brescia
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Palermo
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Italy
State/province [36] 0 0
Vicenza
Country [37] 0 0
Japan
State/province [37] 0 0
Aichi-Ken
Country [38] 0 0
Japan
State/province [38] 0 0
Chiba-Ken
Country [39] 0 0
Japan
State/province [39] 0 0
Kanagawa-Ken
Country [40] 0 0
Japan
State/province [40] 0 0
Kyoto-Fu
Country [41] 0 0
Japan
State/province [41] 0 0
Okayama-Ken
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka-Fu
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Poland
State/province [43] 0 0
Bydgoszcz
Country [44] 0 0
Poland
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Lublin
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Poland
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Sopot
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Poland
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Warszawa
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Spain
State/province [47] 0 0
Vizcaya
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Spain
State/province [48] 0 0
Barcelona
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Spain
State/province [49] 0 0
Lleida
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Spain
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Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Sevilla
Country [52] 0 0
Spain
State/province [52] 0 0
Valencia
Country [53] 0 0
Sweden
State/province [53] 0 0
Malmo
Country [54] 0 0
Sweden
State/province [54] 0 0
Molndal
Country [55] 0 0
Sweden
State/province [55] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03352557