Participants receive 10 mg of Xanamem orally.

Lee Bergman, PhD

Pre-Screening

If you're taking medicine for Alzheimer's, it should have been the same dose and type for the past 3 months.

This asks if your diabetes treatment includes insulin.

You need to avoid caffeine (like coffee, tea, or some sodas) for 4 hours before certain tests during the study.

You need to not smoke or use any tobacco products for 2 hours before certain tests during the study.

List ALL the medications you are currently taking regularly or as needed (including prescription, over-the-counter, and natural like St John's Wort) - if possible, include dosage and frequency.

Could a daily pill help manage the day to day challenges of Alzheimer's disease?

This trial is testing a new potential treatment for people diagnosed with Alzheimer's disease. We want to see if it's safe, tolerable, and can help with memory and cognition problems.

By joining this trial you may help improve our understanding of Alzheimer’s Disease to benefit patients in the future. There is also potential for improvement in cognitive Alzheimer’s Disease symptoms while taking the new potential treatment. Things like your travel to the site will be paid for, and we can even organise this for you. You'll also have access to close medical monitoring and a team that really care.

Alzheimer's disease is a progressive neurological disorder that affects the brain. It leads to cognitive decline, memory loss, and emotional changes, impacting on the indidivdual as well as family and caregivers.

Check your eligibility to participate in this study and help us learn more about this treatment.

Have cognition and memory issues due to Alzheimer's disease.

This trial is all about finding out if a daily pill  can help people with Alzheimer's disease. We want to see if this pill is safe, if people can tolerate it well, and if it actually works to improve the symptoms of Alzheimer's disease.

This study will last for 36 weeks. Participants will be randomly assigned to one of two groups. One group will receive the treatment, and the other group will receive a placebo, which looks like the treatment but has no active ingredients. Neither the participants nor the researchers will know who is receiving the treatment or the placebo until the study is over. This helps us get clear and unbiased results.

Actinogen Medical (ACW) is a pioneering biotechnology company dedicated to advancing a cutting-edge therapy targeting neurological disorders linked to chronically elevated brain cortisol levels. Actinogen are committed to reshaping the landscape of neurological care and improving patients' lives.

Study of Daily Oral Medication for Mild to Moderate Alzheimer's Dementia

The proposed randomized, double-blind, placebo-controlled trial is designed as a follow-up from the XanaMIA-DR trial, to investigate the effects of Xanamem on cognition in patients with mild or moderate dementia due to AD. There is reasonable expectation of potential efficacy, given that: Xanamem has demonstrated improved cognitive performance in domains of working memory and visual attention in healthy, older human volunteers using a CTB at doses of 5, 10, and 20 mg, with improvement seen within 4 weeks of treatment commencing. An improvement has been seen in cognitive and functional abilities in patients with mild AD, selected on the basis of elevated blood p-tau181 levels, on the CDR-SB endpoint. A change from Baseline of 0.6 to 0.8 points versus placebo over 12 weeks is large (Cohen's d = 0.4) and represented a 60% to 80% reduction in progression compared with placebo (ACW0002, Taylor 2024 ). For comparison, the anti-amyloid antibody lecanemab is reported to show an improvement of 0.45 points versus placebo over 18 months in mild cognitive impairment patients with positive amyloid brain scans ( Biogen 2022a ). The proposed patient population has limited treatment options and newer, more effective therapies are sorely needed. Xanamem has the potential to be both cognitively enhancing and disease-modifying.

The trial aims to evaluate the safety, tolerability, and efficacy of Xanamem in patients with mild or moderate dementia due to Alzheimer's Disease. The trial is a Phase 2b/3, double-blind, placebo-controlled, parallel-group study over 36 weeks.

Hunter New England Local Health District

Austin Health

St Vincent's Hospital Sydney

Alzheimer’s Research Australia

CALHN Memory Trials

KaRa Minds

University of the Sunshine Coast Clinical Trials, Birtinya 

Southern Neurology

Could a daily pill help manage the day to day challenges of Alzheimer's disease?

Why Join

What is this trial about?

What are the benefits?

Trial Process

Trial Process

Trial Goals

Alzheimer's Disease

The aim of this trial

Requirements
for participants

Industry Experience

Actinogen Medical

Trial Locations

Check your
eligibility
in two minutes

Check your eligibility

Could a daily pill help manage the day to day challenges of Alzheimer's disease?

Why Join

What is this trial about?

What are the benefits?

Trial Process

Trial Process

Trial Goals

Alzheimer's Disease

The aim of this trial

Requirements for participants

Industry Experience

Actinogen Medical

Trial Locations

Check your eligibility in two minutes

Check your eligibility

Requirements
for participants

Check your
eligibility
in two minutes