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Alzheimers DiseasePhase 2NCT07212062

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 2 study testing X/T + X-EC and Lecanemab 10 mg/kg in people with Alzheimers Disease, run by Neurology Office of South Florida.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimers Disease
What is being tested?
X/T + X-EC and Lecanemab 10 mg/kg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 1. 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:
  • 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.
  • 3. 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.
  • 6. History of ischemic stroke within 12 months prior to the screening visit, or any evidence of hemorrhagic stroke.
  • 7. History of cerebral amyloid angiopathy, epilepsy, CNS neoplasm, or unstable thyroid function.
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  • 8. 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.
  • 9. 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.
  • 10. Participants with any of the following:
  • 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]).
  • 12. 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.
  • 13. History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
  • 14. History of allergy/hypersensitivity to any component (including excipients) of the study intervention or related compounds.
  • 15. History of any of the following:
  • New York Heart Association Class II or greater congestive heart failure
  • Grade 2 or greater angina pectoris
  • Sustained ventricular tachycardia
  • Ventricular fibrillation
  • Torsades de pointes
  • Implantable cardiac defibrillator
  • Myocardial infarction within the 6 months prior to the screening visit.
  • Personal or family history of symptoms of long QT syndrome as evaluated by the investigator.
  • 16. Known acute infection or symptomatic illness within 2 weeks before screening; antigen or polymerase chain reaction local testing can be done at the discretion of the investigator. Rescreening can be permitted after the infection/illness is resolved and consultation with the medical monitor.
  • 17. Participation in another clinical study in which the participant received an experimental or investigational drug within 4 weeks before screening or has participated in more than 2 clinical studies in the 12 months prior to screening.
  • 18. Clinically significant abnormal finding on the physical or neurological examination, ECG, or clinical laboratory results at screening.
  • 19. Any significant pathological findings on historical brain MRI (prior to 14th infusion of Leqembi®) submitted at screening that could impact a participant's safety or interfere with study procedure, including, but not limited to: encephalomalacia, aneurysms, vascular malformations, infective lesions, evidence of any intracranial hemorrhage greater than 10 mm, more than 4 cerebral microbleeds, vasogenic edema, cerebral contusion or infection, more than 1 area of superficial siderosis, evidence of multiple lacunar infarcts (with an axial diameter of < 1.5 cm on neuroimaging) or stroke involving a major vascular territory, severe small vessel disease, or severe white matter disease as defined by a score of 3 on the Fazekas scale; space-occupying lesions or brain tumors (with the exception for meningiomas and arachnoid cysts < 1 cm in greatest diameter, which are permitted).
  • 20. Participants with any of the following:
  • history of unexplained syncope b. history of symptomatic orthostatic hypotension c. history of dysautonomia d. symptomatic orthostatic hypotension (symptomatic reduction of 20 mmHg or more in systolic blood pressure, and/or a symptomatic reduction of 10 mmHg or more in diastolic pressure) at screening. Asymptomatic orthostatic hypotension with a reduction of 20-30 mmHg in systolic blood pressure, and/or a reduction of 10 15 mmHg in diastolic pressure at screening may be eligible and should be discussed with the medical monitor.
  • 21. History of medically significant bradycardia or heart rate < 50 bpm at screening.
  • Reproductive Status 22. Individuals who are pregnant, breastfeeding, or less than 3 months postpartum.
  • 23. Any investigational therapy within 4 weeks prior to screening. 24. Prior exposure to X/T. 25. Currently taking or exposure to within 6 months prior to screening, a disease modifying anti- amyloid treatment for AD except Leqembi®.
  • 26. Unable to taper and discontinue a concomitant medication that would preclude participation in this study (e.g., cannot stop potent anticholinergic or antihistamine medication).
  • 27. No benzodiazepines may be taken within 12 hours prior to cognitive assessments (ADAS- Cog14, MMSE etc) unless taken regularly. If taken regularly, benzodiazepines must be taken at the same time interval prior to all cognitive assessments.
  • 28. Recent history as defined as the past 3 months of receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (e.g., lithium), tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (e.g., lorazepam).
  • Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 12 weeks prior to screening may be permitted.
  • MRTS (Mrazapine) or trazodone may be used as a hypnotic if started at least 8 weeks prior to screening.
  • 29. Inability to comply with restrictions and prohibited treatments as listed in Appendix 4.
  • Physical and Laboratory Test Findings 30. An eGFR of < 50 mL/min. 31. PSA ˃ 10 ng/ML at screening. 32. Elevations in hepatic transaminases at screening ≥ 3 × ULN for ALT and AST and/or bilirubin > 2 × ULN, unless in the context of Gilbert's syndrome.
  • 33. Unstable hypertension or tachycardia as evidenced by:
  • Blood pressure of ≥ 150/100 mmHg (average of triplicate seated measures) at screening.
  • Heart rate of ≥ 100 bpm (average of triplicate seated measures) at screening. 34. Urine toxicology screen positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator).
  • 35. Clinically significant abnormal finding on the physical examination, medical history, ECG (QTcF of > 450 msec in males and > 470 msec in females (as assigned at birth) ), or clinical laboratory results at screening.
  • 36. Vitamin B12 levels below LLN. Other Exclusion Criteria 37. Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply, and Sponsor approval is required).
  • 38. Participants with contraindications to the performance of brain MRI including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in the skull and cardiac devices other than those approved as safe for use in MRI scanners).
  • 39. History of moderate-to-severe alcohol or substance use disorder within the past 2 years.
  • 40. If, in the opinion of the investigator and/or Sponsor/Medical Monitor, participant is unsuitable for enrollment in the study or participant has any finding that, in the view of the investigator and/or Sponsor/Medical Monitor, may compromise the safety of the participant or affect his/her ability to adhere to the protocol visit schedule or fulfil visit requirements.
  • 41. ApoE e4 homozygotes are not eligible. Subjects on anticoagulant therapy must have a stable dose for 4 weeks prior to screening and no history of ischemic or hemorrhagic stroke in the past 12 months or other neurological disorders.
  • -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Brian Costell, MD contact

561-487-1027 ext. 9

CostellResearch@fcneurology.net

Tom Voulgaris, Research Director contact

561-487-1027 ext. 9

tvoulgaris@fcneurology.net

About this study

Official title: 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.

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)

Read the 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.

Being tested
X/T + X-EC, Placebo, Lecanemab 10 mg/kg
Keywords
Alzheimers Disease, Lecanemab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X/T + X-ECDrug

    Xanomeline and Trospium Chloride Capsules

  • PlaceboDrug

    Placebo

  • Lecanemab 10 mg/kgDrug

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

Study groups in NCT07212062
Study groupRoleWhat they receive
Arm A- Lecanemab + X/T + X-ECActive comparatorParticipants will receive the active drug as well as their current Lecanemab treatment.
Receives: Drug: X/T + X-EC; Drug: Lecanemab 10 mg/kg
Arm B- Lecanemab + PlaceboPlacebo comparatorParticipants will receive the non-active drug/placebo as well as their current Lecanemab treatment.
Receives: Drug: Placebo; Drug: Lecanemab 10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Quality of Life in Alzheimers Disease

    Quality of Life-Alzheimer's Disease questionnaire is a measure to ensure the patient and caregiver construct validity and the measure focuses on aspects of life that are relevant to Alzheimer's Diseases. The total scoring sum is 13. The higher the score the better the participants Quality of Life. Questions will be answered as: poor, fair, good and excellent.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07212062
Sponsor's protocol ID
CN012-0117
Other IDs
CN012-0117, CN012-0117
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing X/T + X-EC and Lecanemab 10 mg/kg in people with Alzheimers Disease, run by Neurology Office of South Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Costell, MD (561-487-1027 ext. 9, CostellResearch@fcneurology.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07212062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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