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New pill xanamem aims to slow Alzheimer's decline

NCT ID NCT06125951

Disease control Sponsor: Actinogen Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tests whether a daily 10 mg pill called Xanamem can safely slow memory and function loss in people with mild or moderate Alzheimer's dementia. About 247 participants will receive either Xanamem or a placebo for 36 weeks, with an option to continue the drug for up to 108 weeks. The main goal is to see if the drug improves scores on a standard dementia rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xanamem (a drug taken as a daily pill)
What this could lead to
If successful, Xanamem could become a new daily treatment to slow cognitive and functional decline in early Alzheimer's disease.
What could go wrong
This is a mid-stage trial with only 247 participants, so results may not confirm benefit. The drug is still experimental, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

247 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged 50 years or older, inclusive at the time of Screening. * Clinical syndrome of mild or moderate dementia, likely to be due to AD in the opinion of the Investigator, at Screening, including meeting the following criteria: 1. Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 2. Mini-mental state examination (MMSE) score of 18 to 26 3. Magnetic resonance imaging (MRI) or computerized tomography (CT) scan within 1 year prior to randomization that excludes alternative diagnoses for dementia such as large stroke, likely vascular dementia, brain tumor, subdural hematoma, or other non-AD dementia type findings 4. Positive plasma AD biomarker signature at Pre-screening, comprising fasting levels of a tau species protein. * If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to Screening. * Has a consenting trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant to be able to provide accurate information as to the participant's cognitive and functional abilities. The trial partner must be available to provide information to the Investigator and trial site staff about the participant and agrees to attend all trial site visits in person for scale completion. A trial partner should be available for the duration of the trial. The measure of adequate availability will be at the Investigator's discretion. * Participants must be able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments. * Smokers are eligible if they are able to comfortably abstain from nicotine / tobacco products for 2 hours prior to scheduled cognitive assessments. * Must provide written informed consent to participate in the trial and be willing and able to participate for the maximum of 9 months of treatment and up to 11.5 months of site visits. Exclusion Criteria: * Use of anti-amyloid or anti-tau antibody within 6 months. * Diagnosis of a non-AD dementia including traumatic brain injury. * Diagnosis of an active major mental illness of concern in the opinion in the Investigator, including major depressive disorder, bipolar illness, or schizophrenia. * Participation in another clinical trial of a drug or device * Has a body mass index or body weight that will interfere with participation in the trial, including inadequate venous access to complete the trial assessments, to be determined at the discretion of the Investigator. * Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening. * Clinical diagnosis of Type I or Type II diabetes requiring insulin. * Exhibit physical, cognitive, or language impairments, in the opinion of the Investigator, of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. * Trial participants with evidence of current infection with HIV, hepatitis B, or hepatitis C. * Participants with a history of clinically significant drug abuse or addiction in the past 2 years * Evidence or history of alcohol abuse

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Dementia moderate Dementia, mild

Contacts and locations

Locations

  • ACW Investigative Site 101

    Ivanhoe, Victoria, Australia

  • ACW Investigative Site 102

    Kogarah, New South Wales, Australia

  • ACW Investigative Site 103

    Erina, New South Wales, Australia

  • ACW Investigative Site 104

    Nedlands, Western Australia, Australia

  • ACW Investigative Site 105

    Chermside, Queensland, Australia

  • ACW Investigative Site 106

    Darlinghurst, New South Wales, Australia

  • ACW Investigative Site 107

    Macquarie Park, New South Wales, Australia

  • ACW Investigative Site 108

    Malvern, Victoria, Australia

  • ACW Investigative Site 109

    West Perth, Western Australia, Australia

  • ACW Investigative Site 110

    Woodville South, South Australia, Australia

  • ACW Investigative Site 111

    Newcastle, New South Wales, Australia

  • ACW Investigative Site 112

    Parkville, Victoria, Australia

  • ACW Investigative Site 113

    Birtinya, Queensland, Australia

  • ACW Investigative Site 114

    Bedford Park, South Australia, Australia

  • ACW Investigative Site 115

    Carlton, Victoria, Australia

  • ACW Investigative Site 203

    Delray Beach, Florida, 33445, United States

  • ACW Investigative Site 206

    Toms River, New Jersey, 08755, United States

  • ACW Investigative Site 207

    Decatur, Georgia, 30030, United States

  • ACW Investigative Site 208

    Englewood, Colorado, 80113, United States

  • ACW Investigative Site 209

    Sherman Oaks, California, 91403, United States

  • ACW Investigative Site 210

    Dayton, Ohio, 45459, United States

  • ACW Investigative Site 211

    Denver, Colorado, 80218, United States

  • ACW Investigative Site 212

    Portland, Oregon, 97225, United States

  • ACW Investigative Site 214

    Albany, New York, 12208, United States

  • ACW Investigative Site 215

    Bellevue, Washington, 98007, United States

  • ACW Investigative Site 216

    East Providence, Rhode Island, 02914, United States

  • ACW Investigative Site 217

    Independence, Ohio, 44131, United States

  • ACW Investigative Site 218

    Carlsbad, California, 92011, United States

  • ACW Investigative Site 219

    Staten Island, New York, 10314, United States

  • ACW Investigative Site 220

    Austin, Texas, 78757, United States

  • ACW Investigative site 201

    Miami, Florida, 33176, United States

  • ACW Investigative site 202

    New Port Richey, Florida, 34652, United States

  • ACW Investigative site 204

    Orlando, Florida, 32803, United States

  • ACW Investigative site 205

    The Villages, Florida, 32162, United States

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