Xanamem for Alzheimer's Disease

(XanaMIA Trial)

Recruiting at 46 trial locations

Overseen By Global Program Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Actinogen Medical

Must be taking: Symptomatic AD medications

Must not be taking: Anti-amyloid, Anti-tau

Disqualifiers: Non-AD dementia, Major mental illness, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines Xanamem as a potential treatment for early-stage Alzheimer's Disease. Researchers aim to assess whether Xanamem can alleviate symptoms and how its safety compares to a placebo. Participants will receive either Xanamem or a placebo daily for 36 weeks. Suitable candidates have mild to moderate dementia due to Alzheimer's and have maintained stability on their current medication for at least three months. As a Phase 2 trial, this research measures Xanamem's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in Alzheimer's treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on symptomatic Alzheimer's medications, your dosage must have been stable for 3 months before joining the trial.

Is there any evidence suggesting that Xanamem is likely to be safe for humans?

Research has shown that Xanamem has a promising safety record. Studies have found that this drug is safe and well-tolerated when taken orally. In earlier research, Xanamem was tested on individuals with depression and Alzheimer's disease who exhibited specific measurable signs of these conditions. These studies found that the drug did not cause major side effects, suggesting it might be safe for broader use.

Additionally, studies showed that Xanamem did not improve thinking and memory skills in some groups, but this information enhances understanding of its effects. Researchers are studying the drug for its potential to help with Alzheimer's symptoms and depression. While no major safety issues have been reported, ongoing research will continue to assess its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's Disease?

Unlike the standard Alzheimer's treatments that often focus on reducing symptoms or slowing progression by targeting amyloid plaques or neurotransmitter systems, Xanamem works differently by targeting the 11β-HSD1 enzyme. This enzyme is involved in cortisol production, and by inhibiting it, Xanamem aims to reduce excessive cortisol levels in the brain, which could potentially alleviate cognitive decline. Researchers are excited about this novel approach because it offers a new pathway for slowing or altering the course of Alzheimer's, which might lead to more effective outcomes than current therapies.

What evidence suggests that Xanamem might be an effective treatment for Alzheimer's Disease?

Research has shown that Xanamem, which participants in this trial may receive, might help treat Alzheimer's Disease by targeting cortisol, a stress hormone linked to the condition. Studies in mice found that Xanamem can reduce symptoms and slow the disease's progression. Although short-term use in humans did not show major improvements in cognitive skills, some positive effects appeared in certain areas. This suggests potential benefits, especially for individuals in the early stages of Alzheimer's. Further studies are underway to evaluate how effectively Xanamem can slow the disease in people. ^{1 2 3 5 6}

Who Is on the Research Team?

Global Program Lead

Principal Investigator

Actinogen Medical Ltd

Are You a Good Fit for This Trial?

This trial is for men and women aged 50 or older with mild to moderate dementia due to Alzheimer's, who have specific biomarkers in their blood. They must have had a brain scan within the last year and show cognitive impairment on tests. Stable medication use for 3 months is required, as well as a partner to attend visits and report on the participant's condition.

Inclusion Criteria

You need to be able to avoid drinking any caffeinated drinks for 4 hours before the cognitive tests.

My medication dose for Alzheimer's has been stable for the last 3 months.

I am 50 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg of Xanamem or placebo once daily for 36 weeks

36 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Xanamem

Trial Overview The study tests Xanamem at a dose of 10 mg daily against a placebo over 36 weeks to see if it's safe, tolerable, and effective for early-stage Alzheimer's Disease. Participants are randomly assigned to either treatment or placebo in equal numbers without knowing which they receive (double-blinded).

How Is the Trial Designed?

Group I: 10 mg Xanamem Experimental Treatment 1 Intervention

10 mg Xanamem tablet, to be administered orally once every morning with or without food

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet, to be administered orally once every morning with or without food

Who Is Running the Clinical Trial?

Actinogen Medical

Lead Sponsor

Trials

6

Recruited

760+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38848180/

Plasma pTau181 Predicts Clinical Progression in a Phase ... This trial demonstrates that elevated plasma pTau181 identifies participants more likely to have progressive AD and is a suitable method for enrichment in AD ...

2. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Xanamem_UPDATE3_%28drug_in_development%29.pdf

Xanamem Short-term xanamem treatment did not improve cognition in healthy older people or Alzheimer's patients, except in a few cognitive domains. A phase 2b study in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06125951?cond=Alzheimer%27s%20Disease&term=Xanamem&rank=1

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's ... This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD.

4. nature.com nature.com/articles/d43747-020-00599-y

Targeting cortisol to treat Alzheimer's disease and ... Promising clinical results. Preclinical studies demonstrate that Xanamem is both symptomatic and disease-modifying; in mouse models of Alzheimer's disease, ...

5. firstwordpharma.com firstwordpharma.com/story/5977055

Actinogen confirms 100th participant in XanaMIA phase 2b/ ... Patients receive Xanamem 10 mg or placebo, once daily, and its ability to slow progression of Alzheimer's disease is assessed with a variety of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713383/

Development of Xanamem, an isoform 1 specific inhibitor ... Xanamem also demonstrated potentially disease modifying treatment effects in mild AD in patients with biomarker positive AD (elevation of plasma pTau181) as ...