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Clinical Trials in Poland / NCT05508789
Active, not recruiting Phase 3

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

NCT05508789 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2022-10-10
Last updated
2026-09-22

Condition(s) studied

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Investigational drug(s) / intervention(s)

Donanemab →Placebo

Donanemab: Administered IV

Placebo: Administered IV

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. * A MMSE score of 20 to 28 (inclusive) at screening visit. * Meet amyloid scan (central read) criteria. * Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times. * A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered. * If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments. * Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments * AEs and concomitant medications * CDR, and * ADCS-ADL * Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization. Exclusion Criteria: * Has significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures). * Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months. * History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread. * Contraindication to MRI or PET scans.

Primary outcome measure(s)

Trial sites (141)

FacilityCityRegionStatus
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
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
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) Buenos Aires Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) Buenos Aires Argentina
IDIM - Instituto de Investigaciones Metabólicas Ciudad de Buenos Aires Argentina
INSA Instituto de Neurociencia San Agustin La Plata Argentina
Instituto De Investigaciones Clinicas Quilmes Quilmes Argentina
INECO Neurociencias Oroño Rosario Argentina
Emeritus Research Botany Australia
Box Hill Hospital Box Hill Australia
The Prince Charles Hospital Brisbane Australia
NeuroCentrix Carlton Australia
Central Coast Neurosciences Research Erina Australia
Austin Health Ivanhoe Australia
Southern Neurology Kogarah Australia
HammondCare Malvern Australia
The Alfred Hospital Melbourne Australia
Alzheimer's Research Australia Nedlands Australia
The Royal Melbourne Hospital Parkville Australia
St Vincent's Hospital Sydney Australia
KARA Institute for Neurological Diseases Sydney Australia
Central Coast Neurosciences Research (Tumbi Umbi) Tumbi Vmbi Australia
Neurodegenerative Disorders Research West Perth Australia
The Queen Elizabeth Hospital Woodville Australia
Beijing Hospital Beijing China
Beijing ChaoYang Hospital Beijing China
Beijing Friendship Hospital Affiliate of Capital University Beijing China
Xuanwu Hospital Capital Medical University Beijing China
Beijing Tiantan Hospital Affiliated to Capital Medical University Beijing China
Beijing Anding Hospital - Affiliated Capital University of Medical Science Beijing China
Beijing Peking Union Medical College Hospital Beijing China
Chinese PLA General Hospital Beijing China

+ 101 more sites — see the full list on the official registry below.

On this site

📄 Kisunla (donanemab) drug profile →

More Eli Lilly and Company trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05508789 on ClinicalTrials.gov ↗ ← All trials in Poland