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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06125951
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Actinogen Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Global Program Lead
Principal Investigator Affiliation	Actinogen Medical Ltd
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dementia Moderate, Dementia, Mild, Alzheimer Disease

Arms & Interventions

Arms

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

Interventions

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.

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ACW Investigative Site 218, Carlsbad 5334223, California 5332921

Status

Recruiting

Address

ACW Investigative Site 218

Carlsbad 5334223, California 5332921, 92011

Site Contact

Global Program Lead

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