RECRUITINGPhase 3INTERVENTIONAL
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Donanemab
Administered IV
DRUG
Placebo
Administered IV
Locations (20)
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