AMX0035 and Progressive Supranuclear Palsy

Overview

Información sobre este estudio

The purpose of this study is to assess the impact of AMX0035 compared to placebo on disease progression rate as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Male or female 40 to 80 years of age, inclusive

- Diagnosis of possible or probable PSP Richardson Syndrome

- Presence of PSP symptoms for < 5 years

- Score of < 40 on the total (28-item) Progressive Supranuclear Palsy Rating Scale
(PSPRS)

- Able to walk independently or with minimal assistance

- Minimum score of 24 on the Mini Mental State Examination (MMSE)

- Must reside outside a skilled nursing facility or dementia care facility at the time
of screening. Residence in an assisted living facility is allowed

- Must have a study partner willing to attend study visits and provide information on
participant's status

- Capable of providing informed consent

- Capable and willing to comply with trial procedures including visits to the trial
clinic, visit requirements and treatment schedule, including MRI scans

- Female participants of childbearing potential must agree to use effective birth
control for the duration of the study and for 6 months after last dose of study drug.

- Males must agree to use effective birth control method for the duration of the study
and for 6 months after the last dose of study drug. Men must not plan to donate
sperm..

Exclusion Criteria:

- Require use of a feeding tube

- Evidence of any neurological disorder that could explain signs of PSP

- Evidence of any clinically significant neurological disorder other than PSP, including
significant cerebrovascular abnormalities, vascular dementia, motor neuron disease or
ALS, Huntington's disease, normal pressure hydrocephalus, brain tumor, seizure
disorder, multiple sclerosis, or known structural brain abnormalities.

- History of autosomal dominant PSP due to a Microtubule Associated Protein Tau (MAPT)
mutation

- History of an autosomal dominant mutation associated with Frontotemporal Lobar
Degeneration (FTLD)

- Prior or current diagnosis of schizophrenia, schizoaffective disorder, or bipolar
disorder

- Presence of unstable psychiatric disease, cognitive impairment (e.g., major cognitive
dysfunction), dementia, major depression, or substance abuse that would impair ability
of the participant to provide informed consent and follow instructions

- Abnormal liver function

- Renal insufficiency

- Ongoing anemia

- History of Class III/IV heart failure per New York Heart Association (NYHA)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/29/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

James Bower, M.D.

Abierto para la inscripción

Contact information:

Sherry Klingerman CCRP

(507) 284-0451

klingerman.sherry@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Zbigniew Wszolek, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Audrey Strongosky C.C.R.C.

Strongosky.Audrey2@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Erika Driver-Dunckley, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Hannah Henderson CCRP

(480) 301-6091

Henderson.Hannah2@mayo.edu

More information

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