XanaMIA

Active not recruitingPhase 2 / PHASE3

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

A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial With an Open-Label Extension Phase to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease

Lead sponsor

Actinogen Medical

Asset

Xanamem

Listed sites

Recruiting sites

Enrollment

247

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Tau biomarker required (plasma)•CDR global 0.5-1•MMSE 18-26

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Incidence and severity of treatment-emergent adverse events (TEAEs) [safety

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDACW0009

NCT IDNCT06125951

Timeline

Milestones

Study first posted2023-11-09actual

Study start2024-04-12actual

Last update posted2026-04-23actual

Primary completion2026-10estimated (month precision)

Study completion2028-02estimated (month precision)

Assets

Drug assets

Xanamem

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Global cognition

1 endpoint

Primary/protocol endpoint

Effects of 10 mg Xanamem on integrated cognitive and functional abilities

Time frame:36 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Time frame:36 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.