Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de KarXT + KarX-EC para el tratamiento del deterioro cognitivo asociado a la enfermedad de Alzheimer leve a moderada (MINDSET 1)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06976216Tipo: INTERVENTIONALInicio: 14 de jul de 2025Fin estimado: 23 de feb de 2029

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de KarXT + KarX-EC para el deterioro cognitivo en la enfermedad de Alzheimer.

Elegibilidad

Edad mínima: 60 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Criterios de exclusión

Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.

Intervenciones

drug

KarXT

Specified dose on specified days

drug

KarX-EC

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0088

Banfield, Buenos Aires, Argentina

Site 0088

NOT_YET_RECRUITING

Local Institution - 0001

Buenos Aires, Buenos Aires F.D., Argentina

Site 0001

NOT_YET_RECRUITING

Local Institution - 0271

Buenos Aires, Argentina

Site 0271

NOT_YET_RECRUITING

Fundación Lennox - Instituto Modelo de Neurología

Córdoba, Argentina

Georgina Viczena, Site 0232 · +5493515993881

RECRUITING

Sanatorio Morra S.A.

Córdoba, Argentina

Carlos Morra, Site 0228 · +543514822191

RECRUITING

Instituto Kremer

Córdoba, Argentina

Leonardo Kremer, Site 0085 · 543515000000

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.

Estudio de fase 3, aleatorizado, doble ciego, controlado ... | EligiMed