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CREAD & CREAD2 studies

Clinical Trials Watch

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 1. Studies Information

Scientific title

“A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease”

Study sponsor

Hoffmann- La Roche

Disease

Prodromal to mild Alzheimer’s disease                 

2. Information about the drug that will be tested in the studies

Name of drug

Crenezumab

Administration

  • The drug will be administered via an intravenous infusion (an injection into the vein) once every four weeks
  • The infusion lasts around 60 minutes

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

No

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

  • An intravenous infusion of Crenezumab

OR

  • An intravenous infusion of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested).

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

3. Information about participating in the trials

What are the researchers trying to find out?

The researchers aim to evaluate the efficacy of Crenezumab in people with prodromal or mild Alzheimer’s disease.

How long will the treatment last?

  • Participants will receive an infusion every 4 weeks for 100 weeks (approximately 2 years).
  • Each infusion will last approximately 60 minutes

What will your involvement entail?

  • Participants will have to undergo a PET scan or CSF examination (spinal tap) to see if they have amyloid pathology in their brain.
  • During the study, participants will be asked to complete different tests that will assess their memory, functioning, behaviour, quality of life and medical assessments for overall health.

Further information on the procedures, tests and number of visits can be obtained from the study team.

4. Who can participate in these studies?

Who can participate in these studies?

To take part in these studies, the person must:

  • Have a study partner / informant who has a sufficient contact with the participant, is willing to accompany the participant to all study visits, provides the necessary information about the participant’s memory, behaviour and functioning, and is willing to sign the necessary consent forms.
  • Weight between 40 and 120 kg.
  • Be fluent in the language of the tests used at the study site
  • Have adequate sight and hearing with glasses or hearing aid if required.
  • Have evidence of abnormal accumulation of amyloid in their brain (as per results of CSF examination (spinal tap) or of PET scan).
  • Have an impairment in their memory at screening visit.
  • Have a score between 22-30 points in the MMSE test (a test about your memory) and between 0.5 and 1.0 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment in their memory that is still at a mild stage.
  • Meet the clinical criteria for probable Alzheimer’s dementia or prodromal Alzheimer’s disease of the National Institute on Aging/Alzheimer's Association (NIAAA).
  • 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 3 month prior to the screening visit.

Who cannot participate in these studies?

People cannot take part in the study if they have or have experienced:

  • Any evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological involvement).
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • At risk of suicide in the opinion of the investigator
  • Presence of significant cerebral vascular pathology as assessed by MRI (Magnetic resonance imaging) central reader
  • Unstable or clinically significant cardiovascular, kidney or liver disease or uncontrolled hypertension
  • Poor peripheral venous access (this is when it is difficult to introduce a needle in the veins of the arm or hand of the person).
  • History of cancer except if considered to be cured or if not being actively treated with anti-cancer therapy or radiotherapy
  • Known history of severe allergy or hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.

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

5. Where and when will the studies be conducted?

European countries involved in these trials

CREAD

CREAD2

Austria

X

X

Belgium

X

X

Bulgaria

X

 

Croatia

X

 

Czech Republic

X

 

Denmark

X

planned

Estonia

 

X

Finland

X

 

France

X

X

Germany

X

X

Greece

 

X

Hungary

X

X

Italy

X

X

Lithuania

X

 

Norway

 

X

Poland

X

X

Portugal

X

X

Russian Federation

X

X

Serbia

 

X

Slovenia

X

 

Spain

X

X

Sweden

X

planned

Switzerland

X

 

Turkey

X

X

Ukraine

X

 

United Kingdom

X

X

Estimated start date of recruitment

March 2016

February 2017

6. Information for your doctor

 

CREAD

CREAD2

EudraCT Number

2015-003034-27

2016-003288-20

Clinicaltrials.gov identifier

NCT02670083

NCT03114657

Link to full text

https://clinicaltrials.gov/ct2/show/record/NCT02670083

https://clinicaltrials.gov/ct2/show/NCT03114657

Contact information for both studies

global.rochegenentechtrials@roche.com

Website for both studies

https://www.creadstudy.com/index.aspx

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 these trials (Hoffmann-La Roche) 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: Monday 24 July 2017

 

 
 

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