Un Estudio de Fase 3, Aleatorizado, Doble Ciego, Controlado con Placebo, de Grupos Paralelos para Evaluar la Seguridad y Eficacia de KarXT + KarX-EC para el Tratamiento de la Agitación Asociada con la Enfermedad de Alzheimer

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07011745Tipo: INTERVENTIONALInicio: 16 de jul de 2025Fin estimado: 13 de nov de 2028

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de KarXT + KarX-EC en participantes adultos con agitación relacionada con la Enfermedad de Alzheimer.

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:
i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
ii) If no historical evidence available:
A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
Amyloid PET.
Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:
i) Attend all visits and report on participant's status.
ii) Oversee participant compliance with medication and study procedures.
iii) Participate in the study assessments and provide informed consent to participate in the study.
History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):
i) 1 or more aggressive behaviors occurring at least several times per week.
ii) 2 or more aggressive behaviors occurring at least once or twice per week.
iii) 3 or more aggressive behaviors occurring less than once per week.

Criterios de exclusión

\- Medical Conditions.
i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
\- Prior/Concomitant Therapy.
i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
B. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).

Intervenciones

drug

Xanomeline/Trospium Chloride Capsule

Specified dose on specified days

drug

Xanomeline Enteric Capsule

Specified dose on specified days

drug

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 2005

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site 2005

NOT_YET_RECRUITING

Local Institution - 2006

Buenos Aires, Buenos Aires F.D., Argentina

Site 2006

NOT_YET_RECRUITING

Local Institution - 2004

Buenos Aires, Argentina

Site 2004

NOT_YET_RECRUITING

Local Institution - 2000

Córdoba, Argentina

Site 2000

NOT_YET_RECRUITING

Local Institution - 2002

Córdoba, Argentina

Site 2002

NOT_YET_RECRUITING

Local Institution - 2003

Córdoba, Argentina

Site 2003

NOT_YET_RECRUITING

Local Institution - 2001

Mendoza, Argentina

Site 2001

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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