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)
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) — Baseline, Week 76 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.
Trial sites (141)
Facility
City
Region
Status
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.
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.
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