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

NCT06125951 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ACW0009
• Study Type: interventional
• Target: 247
• Locations: 2 countries
• Sites: 35

Brief 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. 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.

Conditions

Dementia, Mild; Dementia Moderate; Alzheimer Disease

Keywords

Xanamem; Actinogen; Alzheimer's Disease; Cortisol; emestedastat

Outcome Measures

Primary Outcomes (2)

• 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.

  36 weeks

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

  Incidence and severity of TEAEs

  36 weeks

Study Arms (3)

10 mg Xanamem

EXPERIMENTAL

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

Drug: Xanamem

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Open label phase

EXPERIMENTAL

Participants 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

Drug: Xanamem

Interventions

Xanamem DRUG

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.

Also known as: UE2343

10 mg Xanamem; Open label phase

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Actinogen Medical: lead

Study Sites (35)

ACW Investigative Site 218

Carlsbad, California, 92011, United States

Location

ACW Investigative Site 213

Orange, California, 92866, United States

Location

ACW Investigative Site 209

Sherman Oaks, California, 91403, United States

Location

ACW Investigative Site 211

Denver, Colorado, 80218, United States

Location

ACW Investigative Site 208

Englewood, Colorado, 80113, United States

Location

ACW Investigative Site 203

Delray Beach, Florida, 33445, United States

Location

ACW Investigative site 201

Miami, Florida, 33176, United States

Location

ACW Investigative site 202

New Port Richey, Florida, 34652, United States

Location

ACW Investigative site 204

Orlando, Florida, 32803, United States

Location

ACW Investigative site 205

The Villages, Florida, 32162, United States

Location

ACW Investigative Site 207

Decatur, Georgia, 30030, United States

Location

ACW Investigative Site 206

Toms River, New Jersey, 08755, United States

Location

ACW Investigative Site 214

Albany, New York, 12208, United States

Location

ACW Investigative Site 219

Staten Island, New York, 10314, United States

Location

ACW Investigative Site 210

Dayton, Ohio, 45459, United States

Location

ACW Investigative Site 217

Independence, Ohio, 44131, United States

Location

ACW Investigative Site 212

Portland, Oregon, 97225, United States

Location

ACW Investigative Site 216

East Providence, Rhode Island, 02914, United States

Location

ACW Investigative Site 220

Austin, Texas, 78757, United States

Location

ACW Investigative Site 215

Bellevue, Washington, 98007, United States

Location

ACW Investigative Site 106

Darlinghurst, New South Wales, Australia

Location

ACW Investigative Site 103

Erina, New South Wales, Australia

Location

ACW Investigative Site 102

Kogarah, New South Wales, Australia

Location

ACW Investigative Site 107

Macquarie Park, New South Wales, Australia

Location

ACW Investigative Site 111

Newcastle, New South Wales, Australia

Location

ACW Investigative Site 113

Birtinya, Queensland, Australia

Location

ACW Investigative Site 105

Chermside, Queensland, Australia

Location

ACW Investigative Site 114

Bedford Park, South Australia, Australia

Location

ACW Investigative Site 110

Woodville South, South Australia, Australia

Location

ACW Investigative Site 115

Carlton, Victoria, Australia

Location

ACW Investigative Site 101

Ivanhoe, Victoria, Australia

Location

ACW Investigative Site 108

Malvern, Victoria, Australia

Location

ACW Investigative Site 112

Parkville, Victoria, Australia

Location

ACW Investigative Site 104

Nedlands, Western Australia, Australia

Location

ACW Investigative Site 109

West Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular; Alzheimer Disease

Interventions

UE2343

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Global Program Lead

  Actinogen Medical Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 9, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

AU (15); US (20)