Basket | Login

 
 
 
 

ANAVEX®2-73-AD-004

Phase III trials

Click here to download an accessible easy read version of this document.

Study Information

Name of the study

ANAVEX2-73 for Treatment of Early Alzheimer's Disease

Study sponsor

Anavex Life Sciences Corp.

Disease

Early Alzheimer's Disease

Phase

Phase II/III

Information about the drug that will be tested in the studies

Name of the drug

ANAVEX2-73

Administration

Capsules

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 oral capsule of ANAVEX2-73 (high dose) once daily
  • An oral capsule of ANAVEX2-73 (mid dose) once daily
  • An oral capsule of placebo (inactive substance identical in appearance to the drug being tested) once daily.

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 efficacy of ANAVEX2-73 on cognition and function for the treatment of early Alzheimer's disease.

How long will the treatment last?

48 weeks.

What your involvement will entail?

  • During the study, participants will be asked to complete tests that will assess their functioning, behaviour and quality of life (i.e. tests like ADAS-Cog and ADCS-ADL)
  • Complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
  • Complete a questionnaire that assess reported sleep continuity (this is a test called RSCAQ)
  • During the study, participants will have to undergo brain scan (MRI) and CSF examination (spinal tap) to see if they have amyloid pathology in their brain.

Further information on the procedures, tests and 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:

  • Be between 60 and 85 years old
  • Have a diagnosis of mild cognitive impairment due to Alzheimer’s disease or early stage mild dementia due to Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
  • Have a diagnosis of Alzheimer’s disease pathology by an appropriately qualified medical specialist (as per results of CSF examination (spinal tap) or amyloid PET scan)
  • Have a score between 20 and 28 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 stage
  • Have a study partner who has a sufficient contact with the participant (at least 10 hours per week) is willing to participate in study procedures throughout the study duration
  • Have no history of suicides in the past two years.

Who cannot participate in the study?

Exclusion criteria include:

  • Participant who have a progressive medical or neurological condition that in the opinion of the investigator would interfere with the conduct of the study
  • History of clinical hepatic dysfunction or indication of liver disease
  • History of cancer within the last 3 years
  • Contraindication to PET imaging, MRI procedures and lumbar puncture
  • Any results within the previous two years that showed a pathology inconsistent with a diagnosis of Alzheimer’s disease
  • Have any contraindication to brain MRI scans (due to having prostheses, implants, a pacemaker or claustrophobia)
  • Alcohol or drug abuse
  • Any prior exposure to ANAVEX2-73.

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

  • Germany
  • The Netherlands
  • UK

Estimated start date of recruitment

June 2020

Information for your doctor

EudraCT Number

2019-003302-27

Clinicaltrials.gov identifier

NCT03790709

Study contact information

alz@anavex.com

Moyra Coull +441908251492 mcoull@orphan-reach.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03790709

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2021. 

This document has been reviewed by the pharmaceutical company running this trial.

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

 

 

Downloads

 

 

Last Updated: Tuesday 09 February 2021

 

 
 

Options