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DAYBREAK-ALZ study

Clinical Trials Watch

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Study Information

Scientific title

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

Study sponsor

Eli 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 orally 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 receive one of four possible treatments (this is called a randomized study):

  • One tablet of dose 1 of LY331481
  • One tablet of dose 2 of LY331481
  • First one tablet of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested) and then one tablet of dose 1 of LY331481
  • First one tablet of placebo and then one tablet of dose 2 of LY331481

Neither the participant nor their doctor will know the treatment received by the participant (this is called a double-blind study).

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 efficacy of LY3314814 in people with mild Alzheimer's disease dementia.

How long will the treatment last?

Around 3 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 including cognitive assessments and laboratory procedures.

Participants will be asked to undertake brain scans (FAS, FBS) and lumbar punctures (CSF).

Further information on the procedures 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 55 and 85 years old.
  • Have a reliable study partner who cohabits or has regular contact with the participant. The study partner will need to accompany the participant to all study visits.
  • Have results showing that the participant has accumulation of a protein called amyloid in the brain.

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 20-26).
  • Participants will be asked to complete an interview to evaluate the severity or stage of dementia. The score of the Clinical Dementia Rating (CDR) Scale should be 0.5 or 1 (this scale ranges from 0 to 5, with 0 indicating no dementia and 5 severe dementia).

Who cannot participate in the study?

People cannot participate if they have:

  • Any other type of neurological disease that is not Alzheimer’s disease.
  • Some psychiatric disorders.
  • 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 symptoms, 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.
  • Currently enrolled in any other clinical trial involving an investigational product.

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
  • Czech Republic
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russian Federation
  • Spain
  • United Kingdom 

Estimated start date of recruitment

July 2016

Information for your doctor

EudraCT Number:

2015-005625-39

Clinicaltrials.gov identifier

NCT02783573

Study contact information

Eli Lilly and Company   

Contact 1-877-285-4559 or 1-317-615-4559

Link to full text

https://clinicaltrials.gov/ct2/show/record/NCT02783573?term=DAYBREAK-ALZ&rank=1&show_locs=Y

Study website

https://autocruitment.com/daybreak-alz-study

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

The pharmaceutical company running this trial (Eli Lilly) 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 03 August 2017

 

 
 

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