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TANGO

Phase II trials

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Study Information

Scientific title

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

Study sponsor

Biogen

Disease

Mild Cognitive Impairment due to Alzheimer’s disease or mild Alzheimer’s disease

Phase

Phase II

Information about the drug that will be tested in the study

Name of drug

BIIB092

Administration

The drug will be administered via an intravenous infusion (an injection into the vein) every four weeks.

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

  • Low dose of BIIB092 via an intravenous infusion
  • Medium dose of BIIB092 via an intravenous infusion
  • High dose of BIIB092 via an intravenous infusion
  • An intravenous infusion of placebo (inactive substance identical in appearance to the drug being tested).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment due to Alzheimer's disease or with mild Alzheimer's disease.

How long will the treatment last? 

Around 22 months

What will your involvement entail?

  • During the study, participants will be requested to complete tests such as a physical examination, electrocardiogram (recording the electrical activity of the heart) and laboratory tests in order to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
  • Participants will also be asked to complete a test that will assess their memory, orientation, judgment and problem solving, hobbies, personal care and community affairs. Several cognitive tests are used, an example of one of these tests would be the CDR-SB.
  • Further information on the number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 50 and 80 years old
  • Have a progressive change in memory function from more than 6 months
  • Meet clinical criteria for mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease
  • Evidence of cognitive impairment at screening
  • Have a score between 22 and 30 points in the MMSE test (a test about your memory) and 0.5 or 1 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment in their memory that is at a mild stage
  • Have evidence of abnormal accumulation of amyloid in their brain (PET scan)
  • Have a study partner who has a sufficient contact with the participant, provides the necessary information about the participant’s memory, behaviour and functioning.

Who cannot participate in the study?

Exclusion criteria include:

  • Evidence of a neurological condition other than Alzheimer’s disease that may affect the study
  • A clinically significant psychiatric disorder or medical illness such as schizophrenia or major depression 
  • Within the past year history of any of the following: myocardial infarction (heart attack), moderate or severe congestive heart failure, unstable angina, stroke or transient ischemic attack (caused by a temporary disruption in the blood supply to part of the brain)
  • Severe renal or liver disorders
  • Alcohol or drug abuse or dependence within the past year
  • If the person is taking an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for at least 8 weeks prior to the screening visit
  • Treatment with other medications known to potentiate experimental drug’s effects.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study. 

Where and when will the study be conducted?

European countries involved in the trial

  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • Sweden

Estimated start date of recruitment

Mid 2018

Information for your doctor

EudraCT Number

2017-002901-37

Clinicaltrials.gov identifier

NCT03352557

Study contact information

ClinicalTrials@Biogen.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03352557

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2019.

The pharmaceutical company running this trial has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 

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Last Updated: Friday 08 March 2019

 

 
  • Acknowledgements

    Alzheimer Europe's Clinical Trial Watch received funding under an operating grant from the European Union’s Health Programme (2014–2020).
  • European Union
 
 

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