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

Alzheimer Disease Clinical Trial

— XanaMIA  

Official title:

A Phase 2b, Double-Blind, Placebo-Controlled, Parallel-Groups, 36-Week, 2-Arm Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125951
• Other study ID #: ACW0009
• Status: Recruiting
• Phase: Phase 2
• Start date: April 12, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Actinogen Medical
• Contact: Global Program Lead
• Phone: +61 2 8964 7401
• Email: clinicaltrials[@]actinogen.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

5. Cognitive impairment on a symbol coding test of at least 0.5 standard deviations (SD) below the normative data at Screening.

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Moderate
• Dementia, Mild

Intervention

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

Locations

Country	Name	City	State
Australia	ACW Investigative Site 113	Birtinya	Queensland
Australia	ACW Investigative Site 105	Chermside	Queensland
Australia	ACW Investigative Site 106	Darlinghurst	New South Wales
Australia	ACW Investigative Site 103	Erina	New South Wales
Australia	ACW Investigative Site 101	Ivanhoe	Victoria
Australia	ACW Investigative Site 102	Kogarah	New South Wales
Australia	ACW Investigative Site 107	Macquarie Park	New South Wales
Australia	ACW Investigative Site 108	Malvern	Victoria
Australia	ACW Investigative Site 104	Nedlands	Western Australia
Australia	ACW Investigative Site 111	Newcastle	New South Wales
Australia	ACW Investigative Site 112	Parkville	Victoria
Australia	ACW Investigative Site 109	West Perth	Western Australia
Australia	ACW Investigative Site 110	Woodville South	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Actinogen Medical

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of 10 mg Xanamem on cognition	Change from Baseline to end of treatment (EOT) in a custom global cognitive test battery (CTB). The global CTB is calculated as an average Z-score, with higher scores indicating improvement.	36 weeks
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]	Incidence and severity of TEAEs	36 weeks