A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
- Registration Number
- NCT07170150
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
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/Aβ42 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trontinemab Trontinemab Participants will receive intravenous (IV) trontinemab. Placebo Placebo Participants will receive IV placebo.
- Primary Outcome Measures
Name Time Method Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) Baseline - Week 72
- Secondary Outcome Measures
Name Time Method Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants Baseline - Week 72 Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Baseline - Week 72 Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score Baseline - Week 72 Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) Baseline - Week 72 Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) Baseline - Week 72 Change from baseline in CDR-SB Baseline up to but excluding Week 72 Time to increase in Clinical Dementia Rating, Global Score (CDR-GS) Baseline - Week 72 Percentage of participants with adverse events (AEs) Baseline - Week 72 Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings Baseline - Week 72 Percentage of participants with infusion-related reactions (IRR) Baseline - Week 72 Percentage of participants with anti-drug antibodies (ADAs) to trontinemab Baseline - Week 72 Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan Baseline - Week 72 Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants Baseline - Week 72 Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP) Baseline - Week 72
Trial Locations
- Locations (6)
Healthy Brain Clinic
🇺🇸Long Beach, California, United States
Charter Research - Winter Park/Orlando
🇺🇸Orlando, Florida, United States
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Rijikai Medical Corporation Katayama Medical Clinic
🇯🇵Okayama, Japan
Re:Cognition Health Birmingham
🇬🇧Birmingham, United Kingdom
Southampton University Hospitals NHS Trust
🇬🇧Southampton, United Kingdom
Healthy Brain Clinic🇺🇸Long Beach, California, United States