Alzheimers disease
Conditions
Interventions
Sponsors
Christopher Lane
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner -Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) -Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/AB42 ratio may be used as an alternative option if amyloid PET is not available -Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 -Screening MMSE score >=22 and CDR-GS of 0.5 or 1.0 -Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening. -A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order -Availability of a ""study partner"" as defined by the protocol
Exclusion criteria
Exclusion criteria: -Any evidence of a condition other than AD that may affect cognition -History or presence of clinically significant cerebrovascular disease -History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma -History or presence of clinically significant intracranial mass -MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI -Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments -History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, phamacodynamics -Change from baseline through Week 72 in ADAS-Cog-13 -Change from baseline through Week 72 in ADCS-ADL total score and instrumental score -Change from baseline through Week 72 in iADRS -Change from baseline through Week 72 in MMSE -Change from baseline in CDR-SB [Time Frame: Baseline up to but excluding Week 72] -Time to increase in CDR-GS -Percentage of participants with adverse events (AEs) -Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings -Percentage of participants with infusion-related reactions (IRR) -Percentage of participants with anti-drug antibodies (ADAs) to trontinemab -Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan -Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants -Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, AB42 in a subset of participants -Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP) | — |
Countries
Argentina, Australia, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed