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

Trial Summary

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.

What is the purpose of this trial?

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). 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. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion.

Research Team

Global Program Lead

Principal Investigator

Actinogen Medical Ltd

Eligibility Criteria

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

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

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

I am 50 years old or older.

Timeline

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

Treatment Details

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).

Participant Groups

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+