The XanaMIA Phase 2b/3 Alzheimer’s Trial and Open Label Extension Phase

The Phase 2b/3 XanaMIA Open Label Extension is actively enrolling.

Existing and prior participants who complete the main XanaMIA trial may be eligible to continue into the Open Label Extension Phase. Contact your study site for next steps.

This trial is now closed for enrolment

What does the randomized part of the XanaMIA trial involve?

The fully enrolled XanaMIA trial included pre-screening/screening periods followed by 36 weeks  of double-blind randomized Xanamem 10mg or placebo treatment and a four week follow up period.  

‘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.

What is the purpose of the XanaMIA phase 2b/3 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 other aspects of cognition.

This trial investigates the effectiveness of an oral medication called Xanamem® in improving cognitive symptoms and overall clinical function in patients with 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 and may contribute to brain dysfunction.

The trial medication is experimental.

®Xanamem is a registered trademark of Actinogen Medical Limited

What is the Open Label Extension Phase?

The Open Label Extension Phase allows all eligible participants who complete the main XanaMIA trial to continue receiving Xanamem.

In an open label study, all participants receive the active study medication, and both the participant and study doctor know that Xanamem is being administered.

The Open Label Extension Phase provides an opportunity to continue treatment while researchers collect additional information on the long-term safety and tolerability of Xanamem.

What does participation in the Open Label Extension Phase involve?

Participants in the Open Label Extension Phase will need to:

  • Attend clinic visits and telephone visits together with a study partner 
  • Complete interviews (participant and study partner) 
  • Take daily oral Xanamem 
  • Provide blood and urine samples for laboratory testing 
  • Complete questionnaires 
  • Undergo cognitive assessments that evaluate 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 the Open Label Extension Phase?

Participants may be eligible for the Open Label Extension Phase if they:

  • Have completed the main XanaMIA trial and are able to continue participation in the opinion of the study doctor
  • Final eligibility will be determined by the study doctor.

For full study details, including contact information, please visit ClinicalTrials.gov:

Effect of 10 mg Xanamem on Dementia Due to Alzheimer’s Disease (XanaMIA)


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