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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: Active Phase 2 study of Alzheimer Disease and Dementia, Mild, sponsored by Actinogen Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from Baseline to end of treatment (EOT) in the Clinical Dementia Ratio - Sum of Boxes (CDR-SB). The CDR-SB is calculated as an average score, with lower scores indicating improvement.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2024-04-12 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What the registry record for NCT06125951 still lists
NCT06125951 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06125951's enrollment target sits among peer trials
247 92nd of 306 higher than 215 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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