Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
NCT ID: NCT06125951
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2024-04-12
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)
NCT02727699
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers
NCT04983368
Xanamem™ in Healthy Elderly Subjects
NCT03830762
A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease
NCT02353598
An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
NCT03491150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10 mg Xanamem
10 mg Xanamem tablet, to be administered orally once every morning with or without food
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
Placebo tablet, to be administered orally once every morning with or without food
Placebo
Matching placebo which is identical in appearance to the test product (10 mg Xanamem once daily) except that it contains no active ingredient.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Actinogen Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Program Lead
Role: STUDY_DIRECTOR
Actinogen Medical Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ACW Investigative Site 218
Carlsbad, California, United States
ACW Investigative Site 213
Orange, California, United States
ACW Investigative Site 209
Sherman Oaks, California, United States
ACW Investigative Site 211
Denver, Colorado, United States
ACW Investigative Site 208
Englewood, Colorado, United States
ACW Investigative Site 203
Delray Beach, Florida, United States
ACW Investigative site 201
Miami, Florida, United States
ACW Investigative site 202
New Port Richey, Florida, United States
ACW Investigative site 204
Orlando, Florida, United States
ACW Investigative site 205
The Villages, Florida, United States
ACW Investigative Site 207
Decatur, Georgia, United States
ACW Investigative Site 206
Toms River, New Jersey, United States
ACW Investigative Site 214
Albany, New York, United States
ACW Investigative Site 219
Staten Island, New York, United States
ACW Investigative Site 210
Dayton, Ohio, United States
ACW Investigative Site 217
Independence, Ohio, United States
ACW Investigative Site 212
Portland, Oregon, United States
ACW Investigative Site 216
East Providence, Rhode Island, United States
ACW Investigative Site 220
Austin, Texas, United States
ACW Investigative Site 215
Bellevue, Washington, United States
ACW Investigative Site 106
Darlinghurst, New South Wales, Australia
ACW Investigative Site 103
Erina, New South Wales, Australia
ACW Investigative Site 102
Kogarah, New South Wales, Australia
ACW Investigative Site 107
Macquarie Park, New South Wales, Australia
ACW Investigative Site 111
Newcastle, New South Wales, Australia
ACW Investigative Site 113
Birtinya, Queensland, Australia
ACW Investigative Site 105
Chermside, Queensland, Australia
ACW Investigative Site 114
Bedford Park, South Australia, Australia
ACW Investigative Site 110
Woodville South, South Australia, Australia
ACW Investigative Site 115
Carlton, Victoria, Australia
ACW Investigative Site 101
Ivanhoe, Victoria, Australia
ACW Investigative Site 108
Malvern, Victoria, Australia
ACW Investigative Site 112
Parkville, Victoria, Australia
ACW Investigative Site 104
Nedlands, Western Australia, Australia
ACW Investigative Site 109
West Perth, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACW0009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.