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AMARANTH study

Clinical Trials Watch

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Study Information

Scientific title

An Efficacy and Safety Study of LY3314814 in Early Alzheimer's Disease

Study sponsor

Lilly

Disease

Alzheimer’s disease

Information about the drug that will be tested in the study

Name of drug

LY3314814 (also known as AZD3293)

Administration

A tablet taken once a day

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 either receive:

  • One tablet of 20 mgs of LY331481 (study drug)
  • One tablet of 50 mgs of LY3314814 (study drug)
  • One tablet of placebo (a dummy treatment)

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 assess the efficacy and safety of LY3314814 in the treatment of early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type.

How long will the treatment last?

Around 2 years

What will your involvement entail?

During the study, participants will be asked to complete a test that will assess their memory, orientation, judgment and problem solving, hobbies, personal care and community affairs (this is a test called CDR-SB).

Participants will be also requested to complete some other tests that will assess different aspects of their cognition and functioning.

Participants will be asked to undertake scan brains (MRI, PET) or lumbar punctures (CSF).

Further information on the procedures, tests and 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:

  • Have noticed a gradual and progressive change in their memory over more than 6 months. This change should be reported by the participant and by the study partner.
  • Agree to undergo genetic testing (ApoE genotyping)
  • Have a reliable study partner who lives with him/her or with whom the participant has regular contact. The study partner will need to also attend all study visits and be able to comment on changes in the health, ability to perform certain activities, and mental functioning of the participant.

During the screening visit:

  • Participants will be asked to complete a memory test (MMSE). To be able to participate, the score of this test should suggest that the participant has a cognitive impairment that is mild or very mild (i.e. score between 20-30).
  • Participants will be asked to undergo either a brain scan (PET) or a lumbar puncture (CSF). These procedures will help to determine if there are abnormal levels of a protein called amyloid in the brain Only participants who have abnormal levels of amyloid will be able to participate in the study.

 The study includes 2 sub-studies:

  • Participants that undergo a brain scan (PET) at screening will be included in the PET sub-study
  • Participants who undergo a lumbar puncture at screening will be included in the CSF sub-study.

Who cannot participate in the study?

People cannot participate if they have:

  • Any other type of dementia that is not Alzheimer’s disease
  • Serious infection of the brain, Parkinson´s disease, epilepsy or recurrent seizures.
  • Stroke or multiple strokes (brain attack)
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • History of multiple concussions (traumatic brain injury) 
  • Some psychiatric disorders whose symptoms may, in the judgment of the study doctor, make more difficult to interpret the effects of the drug or may affect the participant´s ability to complete the study
  • Alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
  • Within 1 year before the screening or between screening and baseline (i.e. when the participant starts taking the drug), any of the following:
    • myocardial infarction (heart attack);
    • moderate or severe congestive heart failure,
    • hospitalization for, or symptom of, unstable angina;
    • syncope due to orthostatic hypotension or unexplained syncope;
    • known significant structural heart disease or hospitalization for arrhythmia.
    • Congenital QT prolongation (this is a rare inherited or acquired heart condition)
    • History of cancer within the last 5 years, with the exception of some skin cancers, in situ cervical, or non-progressive prostate cancer
    • Other serious or unstable illness that, in the judgment of the investigator, could affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study.

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

  • Belgium
  • France
  • Hungary
  • Italy
  • Germany
  • Poland
  • Romania
  • Spain
  • United Kingdom

Estimated start date of recruitment

September 2014

Completion date

August 2019

Information for your doctor

EudraCT Number

2014-002601-38

Clinicaltrials.gov identifier

NCT02245737

Study contact information

EU_Lilly_Clinical_Trials@lilly.com

Link to full text

https://clinicaltrials.gov/ct2/results?term=NCT02245737&Search=Search&view=record

Study website

http://www.theamaranthstudy.com/about/

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

The pharmaceutical company running this trial (LILLY) has reviewed this document. You can find more information on the trial website: http://www.theamaranthstudy.com/about/

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

 

 

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Last Updated: Friday 10 February 2017

 

 
 

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