The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,500
Hospital Italiano de Buenos Aires
ABB, Argentina
Clinica Privada Banfield
Banfield, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, Argentina
Stat Research S.A.
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Change from Baseline on the iADRS in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology population.
Time frame: Baseline, Week 76
Change from Baseline on the iADRS
Change from baseline on the iADRS in the overall population.
Time frame: Baseline, Week 76
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Change from Baseline CDR-SB in at least one of the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.
Time frame: Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Change from Baseline on the ADAS-Cog13 Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.
Time frame: Baseline, Week 76
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score
Change from Baseline ADCS-iADL Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.
Time frame: Baseline, Week 76
Change from Baseline on the Mini Mental State Examination (MMSE) Score
Change from Baseline on the MMSE Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.
Time frame: Baseline, Week 76
Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan
Change in brain amyloid plaque deposition in the overall population.
Time frame: Baseline, Week 76
Pharmacokinetics (PK): Trough Serum Concentration of Donanemab
Time frame: Baseline to Week 76
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)
Time frame: Week 76
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CIPREC
Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
Centro Médico Arsema
Buenos Aires, Argentina
Instituto Geriatrico Nuestra Señora de Las Nieves
Buenos Aires, Argentina
...and 131 more locations