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ACTIVE NOT RECRUITING Phase 2

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

NCT06125951 · View on ClinicalTrials.gov ↗

Study 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/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. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

Interventions

  • DRUG Placebo
  • DRUG Xanamem

Study Locations (20)

Florida

  • ACW Investigative Site 203 — Delray Beach
  • ACW Investigative site 201 — Miami
  • ACW Investigative site 202 — New Port Richey
  • ACW Investigative site 204 — Orlando
  • ACW Investigative site 205 — The Villages

California

  • ACW Investigative Site 218 — Carlsbad
  • ACW Investigative Site 213 — Orange
  • ACW Investigative Site 209 — Sherman Oaks

Colorado

  • ACW Investigative Site 211 — Denver
  • ACW Investigative Site 208 — Englewood

New York

  • ACW Investigative Site 214 — Albany
  • ACW Investigative Site 219 — Staten Island

Ohio

  • ACW Investigative Site 210 — Dayton
  • ACW Investigative Site 217 — Independence

Georgia

  • ACW Investigative Site 207 — Decatur

New Jersey

  • ACW Investigative Site 206 — Toms River

Oregon

  • ACW Investigative Site 212 — Portland

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2024-04-12
Est. Completion 2028-02
Phase Phase 2

Sponsor

Actinogen Medical

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06125951

The ClinicalTrials.gov registry entry for NCT06125951 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actinogen Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06125951 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06125951 about?

NCT06125951 is a clinical study titled "Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease". 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 part...

What is the current status of trial NCT06125951?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2024-04-12. Estimated completion is 2028-02.

What conditions does trial NCT06125951 study?

This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Mild, Dementia Moderate. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06125951?

The interventions under investigation include: Placebo (DRUG), Xanamem (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06125951?

This trial is sponsored by Actinogen Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06125951 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial