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.

Sponsor
Neurology Office of South Florida
Study ID
NCT07212062
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Dec 1, 2025
Status verified
Sep 2025
Primary completion
Apr 1, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A- Lecanemab + X/T + X-EC
    Participants will receive the active drug as well as their current Lecanemab treatment.
  • Placebo Comparator: Arm B- Lecanemab + Placebo
    Participants will receive the non-active drug/placebo as well as their current Lecanemab treatment.

Primary Outcome Measure

Assess the safety and tolerability of X/T+X-EC compared with placebo in participants with Alzheimer's Disease currently treated with Lecanemab [ Time Frame: Baseline to week 28 as there is a 4 week follow up period after End of Treatment ]

Central Contacts

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