The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03352557
Ethics application status
Date submitted
21/11/2017
Date registered
24/11/2017
Date last updated
15/08/2019

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
Mental Health 0 0 0 0
Other mental health disorders

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
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - 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.
Timepoint [1] 0 0
Up to Week 238
Secondary outcome [1] 0 0
Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) - 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).
Timepoint [1] 0 0
From Baseline to Week 78
Secondary outcome [2] 0 0
Percentage of Participants With Anti-BIIB092 Antibodies in Serum Over Time up to Week 90
Timepoint [2] 0 0
From Baseline up to Week 90

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Caulfield
Recruitment hospital [3] 0 0
Research Site - Heidelberg West
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Parkville
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
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
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
Country [4] 0 0
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
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
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
Country [18] 0 0
France
State/province [18] 0 0
Gironde
Country [19] 0 0
France
State/province [19] 0 0
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
Rhone
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
Germany
State/province [25] 0 0
Baden Wuertemberg
Country [26] 0 0
Germany
State/province [26] 0 0
Baden Wuerttemberg
Country [27] 0 0
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
Country [30] 0 0
Germany
State/province [30] 0 0
Thueringen
Country [31] 0 0
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
Padova
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Italy
State/province [37] 0 0
Vicenza
Country [38] 0 0
Japan
State/province [38] 0 0
Aichi-Ken
Country [39] 0 0
Japan
State/province [39] 0 0
Chiba-Ken
Country [40] 0 0
Japan
State/province [40] 0 0
Kanagawa-Ken
Country [41] 0 0
Japan
State/province [41] 0 0
Kyoto-Fu
Country [42] 0 0
Japan
State/province [42] 0 0
Okayama-Ken
Country [43] 0 0
Japan
State/province [43] 0 0
Osaka-Fu
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo-To
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Sopot
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Spain
State/province [49] 0 0
Vizcaya
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Lleida
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Sevilla
Country [54] 0 0
Spain
State/province [54] 0 0
Valencia
Country [55] 0 0
Sweden
State/province [55] 0 0
Malmo
Country [56] 0 0
Sweden
State/province [56] 0 0
Molndal
Country [57] 0 0
Sweden
State/province [57] 0 0
Stockholm

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03352557
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

Summary results
Other publications