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MissionAD1 & MissionAD2 studies

Clinical Trials Watch

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Studies Information

Scientific title

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease

Study sponsor

Eisai

Disease

Alzheimer’s disease

Information about the drug that will be tested in these studies

Name of drug

Elenbecestat (E2609)

Administration

A tablet taken once daily in the morning

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:

  • One tablet of 50 mg of elenbecestat
  • One placebo tablet (also called a dummy treatment which is an 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 (this is called a double-blind study).

Information about participating in the trials

What are the researchers trying to find out?

  • The purpose of these studies is to evaluate the efficacy and safety of treatment with elenbecestat in participants with early Alzheimer’s disease.

How long will the treatment last?

2 years

What will your involvement entail?

During these studies, participants will be asked to:

  • Complete a test that will assess their memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
  • Complete a memory test (MMSE)
  • Complete some other tests to evaluate impaired function and possible cognitive impairment (i.e. FAQ, ADAS-Cog)
  • Undertake brain scans (PET, MRI) or lumbar punctures (CSF).

Further information on the procedures can be obtained from the studies team.

Who can participate in these studies?

Who can participate in these studies?

To take part in these studies, participants must:

  • Be between 50 and 85 years old
  • Have a reliable study partner who has frequent contact with the participant. The study partner will support the participant for duration of the study
  • Have a Clinical Dementia Rating (CDR) Scale of 0.5 (the CDR is a scale used to evaluate the severity or stage of dementia. This scale ranges from 0 to 5, with 0 indicating no dementia and 5 severe dementia)
  • Have noticed changes in their memory. This change must be confirmed by a computerised list learning task
  • Have results of a lumbar puncture (CSF) or a brain scan (PET) showing that the participant has accumulation of a protein called amyloid in the brain.

Who cannot participate in these studies?

People cannot participate if they have:

  • Within 5 years before the screening, any of the following:
    • History of seizures
    • Malignant neoplasms (this commonly refers to a tumour that tends to grow)
  • Major depressive episode or psychiatric diagnosis
  • Alcohol or drug abuse or dependence
  • Severe visual of hearing impairment
  • A pregnancy or lactation for female subjects
  • Have participated in a recent clinical study (e.g. this exclusion period could be of 6 months duration if people participated into a study with a drug indicated for Alzheimer's disease).

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

Where and when will the studies be conducted?

European countries involved in these trials

MissionAD1

MissionAD2

Czech Republic

planned

planned

Denmark

 

planned

Finland

 

planned

France

planned

planned

Germany

planned

planned

Greece

planned

 

Italy

 

planned

Poland

X

planned

Portugal

 

planned

Slovakia

 

planned

Spain

planned

X

Sweden

planned

 

United Kingdom

planned

 

Estimated start date of recruitment

2017

Information for your doctor

 

MissionAD1

MissionAD2

EudraCT Number

2016-003928-23

2016-004128-42

Clinicaltrials.gov identifier

NCT02956486

NCT03036280

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT02956486?term=missionAD1&rank=1&show_locs=Y#locn

https://clinicaltrials.gov/ct2/show/NCT03036280?term=missionad2&rank=1

Contact information for both studies

Eisai Medical Services

Contact 1-888-422-4743

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on August 2017.

The pharmaceutical company running this trial (Eisai) 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: Thursday 10 August 2017

 

 
 

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