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 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 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?

Adults ages 50 years and older

  • Diagnosis of likely Alzheimer’s disease of mild to moderate degree
  • Have noticed difficulty with memory, attention, concentration, decision-making, and doing complex tasks
  • Does not have diagnosed serious impairment of kidney, liver, lung, or heart function
  • Other medical conditions and medications may be acceptable if stable
  • Has not received therapy with an anti-amyloid antibody within the last 6 months
  • Has a ‘trial partner’ who knows the study participant well and would be available for the duration of the study.

For full information including contact information please click this link:

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

How to participate in the XanaMIA trial

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

Clinical Trial Site locations

This trial has started screening participants in Australia.

Locations available to date are:

NSW

Darlinghurst NSW

Erina NSW

Kogarah NSW

Macquarie Park NSW

Newcastle NSW

QLD

Birtinya QLD

SA

Woodville South SA

VIC

Ivanhoe VIC

Malvern VIC

Parkville VIC

WA

Nedlands WA

West Perth WA


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