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.

NCT07212062 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CN012-0117
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Alzheimers Disease

Keywords

Alzheimers Disease; Lecanemab

Outcome Measures

Primary Outcomes (1)

• Assess the safety and tolerability of X/T+X-EC compared with placebo in participants with Alzheimer's Disease currently treated with Lecanemab

  Incidence of AEs/SAEs/AESIs/AEs leading to study intervention discontinuation, AEs leading to death through week 24.

  Baseline to week 28 as there is a 4 week follow up period after End of Treatment

Secondary Outcomes (1)

• Quality of Life in Alzheimers Disease

  Three different time points from Baseline to Week 24 will be assessed.

Study Arms (2)

Arm A- Lecanemab + X/T + X-EC

ACTIVE COMPARATOR

Participants will receive the active drug as well as their current Lecanemab treatment.

Drug: X/T + X-EC; Drug: Lecanemab 10 mg/kg

Arm B- Lecanemab + Placebo

PLACEBO COMPARATOR

Participants will receive the non-active drug/placebo as well as their current Lecanemab treatment.

Drug: Placebo; Drug: Lecanemab 10 mg/kg

Interventions

X/T + X-EC DRUG

Xanomeline and Trospium Chloride Capsules

Arm A- Lecanemab + X/T + X-EC

Placebo DRUG

Placebo

Arm B- Lecanemab + Placebo

Lecanemab 10 mg/kg DRUG

Participants will continue their current Lecanemab infusions while in the study receiving the study drug or placebo.

Arm A- Lecanemab + X/T + X-EC; Arm B- Lecanemab + Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of Participant and Target Disease Characteristics 2. A diagnosis of AD
• A confirmed clinical diagnosis of Alzheimer's disease and AD pathology verified by a Health Authority-approved assay. Participants must have received treatment with commercially available Lecanemab (10 mg/kg IV every two weeks) and must have completed at least 14 infusions prior to screening.
• \. BMI within 18 to 35 kg/m2 inclusive. 4. MMSE score 16-24 (inclusive) at screening; 5. Historical MRI prior to 14th infusion of Leqembi®. 6. Participant has a stable living environment for at least 6 weeks prior to screening. Participants are eligible if they are in nursing homes, assisted living facilities, memory care facilities, or living at home.
• \. The participant has sufficient verbal ability to satisfactorily comply with the study procedures (corrective measures such as hearing aids and reading glasses are allowed, if necessary) and is willing and able to attend clinic visits. Participants who use wheelchairs or other ambulatory assistive devices are permitted to enter this study.
• \. Caregiver/study partner must be willing to comply with scheduled visits and protocol standards. In addition; the caregiver/study partner must be in contact with the participant frequently enough to accurately report on the participant's symptoms and on participant's adherence to the study drug schedule, in the investigator's opinion. The caregiver/study partner must be fluent in the local language in which the study assessment will be conducted. The caregiver/study partner must agree to participate in study assessments and provide written consent to participate in the study.
• \. The participant must be willing and able to discontinue all prohibited concomitant medications to meet protocol washout and medication stability requirements before randomization. Investigators should not withdraw a participant's prohibited medication for the purpose of enrolling them into the study unless discontinuation of the medication is deemed to be clinically appropriate (e.g., symptoms are not well-controlled, or the participant cannot tolerate the current medication).
• \. In premorbid state, participant had sufficient literacy and arithmetic proficiency to allow completion of the cognitive assessments.
• Age of Participant 11. Participant must be 60 to 85 years, inclusive, at the time of signing the ICF.
• \. Female (as assigned at birth) participants who are not of childbearing potential (as defined in Appendix 3) must have documented proof. Documentation can be obtained from the site personnel's review of the participant's medical records, medical examination, or medical history interview.
• IOCBP must have a negative highly sensitive pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention.
• IOCBP must agree to follow instructions for method(s) of contraception as described below and included in the ICF. IOCBP are permitted to use hormonal contraceptive methods (as described in Appendix 3).
• \. A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
• Is not an IOCBP OR
• Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), preferably with user independent methods as described in Appendix 3, during the intervention period and for at least 16 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
• \. Male participants should maintain their usual practice regarding contraception (if any); however, no specific or additional contraceptive measures are required.

You may not qualify if:

• \. Risk of suicidal behaviour during the study as determined by the investigator's clinical assessment and/or C-SSRS (baseline version) as confirmed by the following:
• a. Answers "Yes" on items 4, or 5 (C-SSRS-ideation) with the most recent episode occurring within the 2 months before screening or, b. Answers "Yes" to any of the 5 items (C-SSRS-behavior) with an episode occurring within the 12 months before screening 2. Any current primary psychiatric diagnosis (e.g., major depression, schizoaffective disorder, bipolar disorder) or severe psychiatric symptoms (e.g., hallucination, agitation or delusions) if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of treatment effect, affect cognitive assessment, or may impact the participants ability to complete the study.
• \. Participants with history of schizophrenia or other chronic psychosis. 4. Any prior or on-going uncontrolled/unstable psychiatric disorder that could interfere with study assessments.
• Medical Conditions 5. History or presence of clinically significant cardiovascular (e.g., untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (e.g., obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
• \. History of ischemic stroke within 12 months prior to the screening visit, or any evidence of hemorrhagic stroke.
• \. History of cerebral amyloid angiopathy, epilepsy, CNS neoplasm, or unstable thyroid function.
• \. History or high risk of urinary retention (for male participants, includes PVR urine volume \> 150 mL at screening; re-test is permitted when PVR urine volume is 151 through 175 mL at screening), gastric retention, or narrow-angle glaucoma.
• \. Active biliary disease (e.g., symptomatic gallstones, cholangitis, biliary sphincter contraction, cholecystitis). A history of other biliary disease may be eligible and should be discussed with the medical monitor.
• \. Participants with any of the following:
• a. history of bladder stones b. history of recurrent urinary tract infections c. For male participants, serum prostate-specific antigen \>10 ng/mL at screening d. For male participants, an IPSS score of 5 (i.e., "almost always") on items 1, 3, 5, or 6 e. For male participants, an IPSS score ≥ 9 for the sum of items 1, 3, 5, and 6 11. All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]).
• \. Participants with HIV with detectible viral load, HCV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or LFT results.
• \. History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
• \. History of allergy/hypersensitivity to any component (including excipients) of the study intervention or related compounds.
• \. History of any of the following:
• New York Heart Association Class II or greater congestive heart failure

Sponsors & Collaborators

• Neurology Office of South Florida: lead
• Bristol-Myers Squibb: collaborator

Related Publications (1)

• 20. Cobenfy (trospium-xanomeline). Package insert. Bristol-Myers Squibb Company; 2024.

  BACKGROUND

Related Links

• Bristol- Myers Squibb

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Brian Costell, MD

  Neurology Office of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Costell, MD

CONTACT

561-487-1027; CostellResearch@fcneurology.net

Tom Voulgaris, Research Director

CONTACT

561-487-1027; tvoulgaris@fcneurology.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-09