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NCT06125951 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Alzheimer Disease and Dementia, Mild, sponsored by Actinogen Medical.

Active
Registry status
Phase 2
Development phase
247
Enrollment target
20
Study locations

NCT06125951 is a Phase 2 study of Alzheimer Disease and Dementia, Mild that is active but no longer recruiting, run by Actinogen Medical. The registered enrollment target is 247 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06125951, a Phase 2 study of Alzheimer Disease and Dementia, Mild, is active but no longer recruiting, sponsored by Actinogen Medical.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
247 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Alzheimer Disease Dementia, Mild Dementia, Moderate

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

2 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, categorized as Phase 2. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower). The listed sponsor is Actinogen Medical, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT06125951 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Colorado.

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.

What interventions are being tested in trial NCT06125951?

The interventions under investigation include: Placebo (DRUG), Xanamem (DRUG).

Who is sponsoring clinical trial NCT06125951?

This trial is sponsored by Actinogen Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.