A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

CompletadoFase 2ClinicalTrials.gov

ID: NCT04592874Tipo: INTERVENTIONALInicio: 22 de ene de 2021Fin estimado: 12 de sept de 2024

Traducción no disponible, mostrando original

Resumen

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Descripción detallada

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Criterios de exclusión

Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
History or evidence of clinically significant brain disease other than AD.
Females who are pregnant or breastfeeding, or planning to conceive within the study period.
Any experimental vaccine or gene therapy.
History of unresolved cancer.
Current use of anticoagulant medications.
Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
Participant is positive for presence of APOE e4/e4 genotype.

Intervenciones

drug

AL002

Administered via intravenous (IV) infusion

drug

Placebo

Administered via intravenous (IV) infusion

Ubicaciones

Instituto Kremer

Córdoba, Argentina

Centro de Psiquiatría Biológica Instituto Senecta

Mendoza, Argentina

Patrocinadores

PrincipalAlector Inc.

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