AzTrials
AzTrials

Dementia ModeratePhase 2/3XanaMIANCT06125951

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

A Phase 2/3 study testing Xanamem in people with Dementia Moderate and Dementia, Mild, run by Actinogen Medical at 34 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Xanamem
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
34 sitesin 2 countries
Study dates
12 Apr 2024to Feb 2028
Phase
Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Clinical Dementia Rating (CDR) global score of 0.5 to 1.0
  • Mini-mental state examination (MMSE) score of 18 to 26
  • 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
  • Positive plasma AD biomarker signature at Pre-screening, comprising fasting levels of a tau species protein.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States19 sites

  • ACW Investigative Site 214

    Albany, New York, 12208

  • ACW Investigative Site 220

    Austin, Texas, 78757

  • ACW Investigative Site 215

    Bellevue, Washington, 98007

  • ACW Investigative Site 218

    Carlsbad, California, 92011

  • ACW Investigative Site 210

    Dayton, Ohio, 45459

  • ACW Investigative Site 207

    Decatur, Georgia, 30030

  • ACW Investigative Site 203

    Delray Beach, Florida, 33445

  • ACW Investigative Site 211

    Denver, Colorado, 80218

  • ACW Investigative Site 216

    East Providence, Rhode Island, 02914

  • ACW Investigative Site 208

    Englewood, Colorado, 80113

  • ACW Investigative Site 217

    Independence, Ohio, 44131

  • ACW Investigative Site 206

    Marlton, New Jersey, 08053

  • ACW Investigative site 201

    Miami, Florida, 33176

  • ACW Investigative site 202

    New Port Richey, Florida, 34652

  • ACW Investigative site 204

    Orlando, Florida, 32803

  • ACW Investigative Site 212

    Portland, Oregon, 97225

  • ACW Investigative Site 209

    Sherman Oaks, California, 91403

  • ACW Investigative Site 219

    Staten Island, New York, 10314

  • ACW Investigative site 205

    The Villages, Florida, 32162

Other trials in United States

Australia15 sites

  • ACW Investigative Site 114

    Bedford Park, South Australia

  • ACW Investigative Site 113

    Birtinya, Queensland

  • ACW Investigative Site 115

    Carlton, Victoria

  • ACW Investigative Site 105

    Chermside, Queensland

  • ACW Investigative Site 106

    Darlinghurst, New South Wales

  • ACW Investigative Site 103

    Erina, New South Wales

  • ACW Investigative Site 101

    Ivanhoe, Victoria

  • ACW Investigative Site 102

    Kogarah, New South Wales

  • ACW Investigative Site 107

    Macquarie Park, New South Wales

  • ACW Investigative Site 108

    Malvern, Victoria

  • ACW Investigative Site 104

    Nedlands, Western Australia

  • ACW Investigative Site 111

    Newcastle, New South Wales

  • ACW Investigative Site 112

    Parkville, Victoria

  • ACW Investigative Site 109

    West Perth, Western Australia

  • ACW Investigative Site 110

    Woodville South, South Australia

Other trials in Australia

About this study

Official title: A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial With an Open-Label Extension Phase to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease

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. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

Being tested
Xanamem, Placebo
Keywords
Xanamem, Actinogen, Alzheimer's Disease, Cortisol, emestedastat
Medical subject headings
Dementia, Lymphoma, Follicular, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XanamemDrug

    Also called UE2343

    Xanamem drug product is formulated as an immediate-release film-coated tablet formulation for oral administration. Each Xanamem tablet contains 10 mg Xanamem (UE2343) drug substance and excipients.

  • PlaceboDrug

    Matching placebo which is identical in appearance to the test product (10 mg Xanamem once daily) except that it contains no active ingredient.

Study groups in NCT06125951
Study groupRoleWhat they receive
10 mg XanamemExperimental10 mg Xanamem tablet, to be administered orally once every morning with or without food
Receives: Drug: Xanamem
PlaceboPlacebo comparatorPlacebo tablet, to be administered orally once every morning with or without food
Receives: Drug: Placebo
Open label phaseExperimentalParticipants enrolled in the open-label phase after the main trial will receive 10 mg Xanamem, to be administered orally once every morning with or without food
Receives: Drug: Xanamem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of 10 mg Xanamem on integrated cognitive and functional abilities

    Change from Baseline to end of treatment (EOT) in the Clinical Dementia Ratio - Sum of Boxes (CDR-SB). The CDR-SB is calculated as an average score, with lower scores indicating improvement.

    Measured: 36 weeks

  2. Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]

    Incidence and severity of TEAEs

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start12 Apr 2024
  3. Primary completion22 Sep 2026
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After completion of the randomized, placebo-controlled, parallel-group main trial, participants who have completed the main trial will be eligible to take part in an open-label phase with 10 mg Xanamem
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06125951
Sponsor's protocol ID
ACW0009
Acronym
XanaMIA
Status last verified
Oct 2026
First submitted
23 Oct 2023
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in