The XanaMIA Phase 2b Alzheimer's Trial

What is the purpose of the XanaMIA phase 2b trial in mild to moderate Alzheimer’s disease?

The purpose of the trial is to test a potential new treatment for improving cognitive performance, including issues with memory, concentration, decision-making and the like.

This trial investigates the effectiveness of an oral medication called Xanamem® in improving cognitive symptoms in patients with MCI or mild or moderate dementia due to AD.

Xanamem was created to block the excess production of cortisol – the stress hormone – inside brain cells. High levels of cortisol are often seen in people with Alzheimer’s disease.

The trial medication is experimental.

®Xanamem is a registered trademark of Actinogen Medical Limited

What does the trial involve?

Participation in the trial will be required for approximately 11.5 months (50 weeks). This includes a pre-screening period (if required) of 6 weeks, a screening period of up to 4 weeks, a treatment period of 9 months (36 weeks) and a follow-up period of 4 weeks.

‘Randomized’ means that you will be assigned by chance (like flipping a coin) to receive either the research project treatment or a placebo (no active ingredients).

‘Double-blind’ means neither doctor, participant, nor Actinogen will know which treatment was assigned at randomization.

Participants in the XanaMIA-B trial will need to:

  • Attend appointments at a clinical trial site and appointments via telephone together with a study partner
  • Undergo interviews (participant and study partner)
  • Take a daily oral medication
  • Have blood and urine samples collected for laboratory testing
  • Complete various questionnaires
  • Undergo cognitive assessments that will evaluate functions such as memory, concentration, and decision-making

Is there a cost?

There is no cost to participate in this clinical trial.

Reimbursement for reasonable travel and incidental costs incurred attending clinic visits will be provided.

Who is eligible for this study?

Main participation criteria:

  • Adults aged 50 years and older 
  • Clinical syndrome of mild or moderate dementia, likely to be due to AD
  • Have noticed difficulty with memory, attention, concentration, decision-making, and thinking
  • Have a trial partner

More details on the study, including the eligibility criteria, will be published on a public database soon. 

How to participate in the XanaMIA trial

Contact the nearest clinical trial site directly to discuss the trial and, if eligible, book a screening visit with the site.

Clinical Trial Site locations

This trial will start enrolling in Australia.

Locations will be updated once clinical trial sites are activated.

More information

To learn more about the XanaMIA trial and/or to register interest, please contact clinicaltrials@actinogen.com.au


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