Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06125951




Registration number
NCT06125951
Ethics application status
Date submitted
23/10/2023
Date registered
9/11/2023
Date last updated
21/05/2024

Titles & IDs
Public title
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
ACW0009
Universal Trial Number (UTN)
Trial acronym
XanaMIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia Moderate 0 0
Dementia, Mild 0 0
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xanamem
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Matching placebo which is identical in appearance to the test product (10 mg Xanamem once daily) except that it contains no active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effects of 10 mg Xanamem on cognition
Timepoint [1] 0 0
36 weeks
Primary outcome [2] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
Timepoint [2] 0 0
36 weeks

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
ACW Investigative Site 106 - Darlinghurst
Recruitment hospital [2] 0 0
ACW Investigative Site 103 - Erina
Recruitment hospital [3] 0 0
ACW Investigative Site 102 - Kogarah
Recruitment hospital [4] 0 0
ACW Investigative Site 107 - Macquarie Park
Recruitment hospital [5] 0 0
ACW Investigative Site 111 - Newcastle
Recruitment hospital [6] 0 0
ACW Investigative Site 113 - Birtinya
Recruitment hospital [7] 0 0
ACW Investigative Site 105 - Chermside
Recruitment hospital [8] 0 0
ACW Investigative Site 110 - Woodville South
Recruitment hospital [9] 0 0
ACW Investigative Site 101 - Ivanhoe
Recruitment hospital [10] 0 0
ACW Investigative Site 108 - Malvern
Recruitment hospital [11] 0 0
ACW Investigative Site 112 - Parkville
Recruitment hospital [12] 0 0
ACW Investigative Site 104 - Nedlands
Recruitment hospital [13] 0 0
ACW Investigative Site 109 - West Perth
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Erina
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Macquarie Park
Recruitment postcode(s) [5] 0 0
- Newcastle
Recruitment postcode(s) [6] 0 0
- Birtinya
Recruitment postcode(s) [7] 0 0
- Chermside
Recruitment postcode(s) [8] 0 0
- Woodville South
Recruitment postcode(s) [9] 0 0
- Ivanhoe
Recruitment postcode(s) [10] 0 0
- Malvern
Recruitment postcode(s) [11] 0 0
- Parkville
Recruitment postcode(s) [12] 0 0
- Nedlands
Recruitment postcode(s) [13] 0 0
- West Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Actinogen Medical
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06125951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Program Lead
Address 0 0
Actinogen Medical Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Program Lead
Address 0 0
Country 0 0
Phone 0 0
+61 2 8964 7401
Fax 0 0
Email 0 0
clinicaltrials@actinogen.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06125951