Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Public ClinicalTrials.gov record NCT06125951. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06125951
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2024 (Actual)
- Primary completion
- Sep 22, 2026 (Actual)
- Completion
- Feb 2028 (Estimated)
- Last update posted
- Oct 13, 2026
2024 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ACW Investigative Site 218 | Carlsbad | California | 92011 | — |
| ACW Investigative Site 209 | Sherman Oaks | California | 91403 | — |
| ACW Investigative Site 211 | Denver | Colorado | 80218 | — |
| ACW Investigative Site 208 | Englewood | Colorado | 80113 | — |
| ACW Investigative Site 203 | Delray Beach | Florida | 33445 | — |
| ACW Investigative site 201 | Miami | Florida | 33176 | — |
| ACW Investigative site 202 | New Port Richey | Florida | 34652 | — |
| ACW Investigative site 204 | Orlando | Florida | 32803 | — |
| ACW Investigative site 205 | The Villages | Florida | 32162 | — |
| ACW Investigative Site 207 | Decatur | Georgia | 30030 | — |
| ACW Investigative Site 206 | Marlton | New Jersey | 08053 | — |
| ACW Investigative Site 214 | Albany | New York | 12208 | — |
| ACW Investigative Site 219 | Staten Island | New York | 10314 | — |
| ACW Investigative Site 210 | Dayton | Ohio | 45459 | — |
| ACW Investigative Site 217 | Independence | Ohio | 44131 | — |
| ACW Investigative Site 212 | Portland | Oregon | 97225 | — |
| ACW Investigative Site 216 | East Providence | Rhode Island | 02914 | — |
| ACW Investigative Site 220 | Austin | Texas | 78757 | — |
| ACW Investigative Site 215 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06125951, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06125951 live on ClinicalTrials.gov.