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ETHERAL

Phase II trials

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Study Information

Scientific title

A study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients with mild-moderate Alzheimer's Disease

Study sponsor

Oryzon Genomic

Disease

Mild-moderate Alzheimer's disease

Phase

Phase II

Information about the drug that will be tested in the study

Name of drug

ORY-2001

Administration

A capsule 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 the following options:

  • A capsule of 0.6 mg of ORY-2001
  • A capsule of 1.2 mg of ORY-2001
  • A placebo capsule (a substance identical in appearance to the drug being tested with no active therapeutic effect). 

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 two doses of ORY-2001 in patients with mild-moderate Alzheimer's disease.

How long will the treatment last? 

24 weeks and 24 week extension

What will your involvement entail?

During the study, participants will be asked to:

  • Complete some laboratory tests to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • Do physical examination and an electrocardiogram (a test that records the electrical activity of the heart)
  • Complete a questionnaire that will assess their agitation (this is a test called CMAI) and apathy (this is a test called AES-C)
  • 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. ADAS-Cog).

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 50 and 85 years old
  • Meet clinical criteria for probable Alzheimer’s disease (according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Have a score between 16 and 26 points in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild or very mild stage
  • Have evidence of abnormal accumulation of amyloid and Tau protein in their brain (CSF)
  • Have a study partner who has a sufficient contact with the participant, provides the necessary information about the participant’s memory, behaviour and functioning
  • Formal education for more than 6 years
  • If the person is taking medication to treat symptoms related to Alzheimer’s disease, the dosing regimen must have been stable for at least 6 months
  • If the person is taking a treatment for any other chronic condition, the dosing regimen must have been stable for a least one month
  • Use highly efficient contraception (for fertile and male female).

Who cannot participate in the study?

Exclusion criteria include:

  • A psychiatric disorder or a cancer that according to the investigator might confound the study results
  • Uncontrolled hypertension, diabetes or hepatic impairment (persistent liver inflammation
  • Participation in another clinical trial with an investigational drug not completed within the 30 days prior to enrolment
  • Abnormal clinical evaluation on electrocardiogram (a test that records the electrical activity of the heart), haematology (blood tests) or biochemistry laboratory tests values (including kidney function profile)
  • A pregnancy or breast-feeding for female participants
  • Alcohol or drug abuse or dependence.

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 (active)

  • Spain

European countries involved in the trial (planned)

  • France
  • UK

Estimated start date of recruitment

May 2018

Information for your doctor

EudraCT Number

2017-004893-32

Study contact information

dgualteros@oryzon.com
 info@oryzon.com

Link to full text

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002838-23

The information contained in this document is based on information available on public registries (e.g. EU clinical trials register 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: Thursday 07 February 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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