NCT07212062

The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.

A Phase II, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Sfatey and Tolerability of X/T+X-EC vs. Placebo in Participants With Alzheimer's Disease Currently Treated With Lecanemab.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Neurology Office of South Florida · Network
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of the trial is to see if the Safety and Tolerability of X/T+X/T-EC combined with currently treated Lecanemab participants with Alzheimer's Disease compared with placebo. This is a 32 week study (4 weeks of screening,24 weeks of treatment and 4 weeks of safety follow up)

Detailed description

Phase II, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of X/T+X-EC vs. placebo in participants with Alzheimer's Disease currently treated with Lecanemab. 32 week study. 60 participants (60-85 years of age), 3 US sites. A caregiver/LAR will be utilized for each participant. LAR must be knowledgeable of the participant and spends no less than 10 hours per week with them. Participants must have received treatment with commercially available Lecanemab and must have completed at least 14 infusions prior to screening. Eligible participants will continue with their treatment of Lecanemab. If qualified for the study, the participants will be randomized to either the study drug provided X/T+X-EC or placebo. The radnomization will be performed by the RTSM system.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
DRUG	X/T + X-EC	Xanomeline and Trospium Chloride Capsules
DRUG	Placebo	Placebo
DRUG	Lecanemab 10 mg/kg	Participants will continue their current Lecanemab infusions while in the study receiving the study drug or placebo.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-04-01
• Completion: 2028-12-30
• First posted: 2025-10-08
• Last updated: 2025-10-08

Regulatory

• FDA-regulated drug study