A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (NCT07170150) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
United States800 participantsStarted 2025-11-12
Plain-language 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).
Who can participate
Age range50 Years – 90 Years
SexALL
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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…
What they're measuring
1
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Timeframe: Baseline - Week 72
Trial details
NCT IDNCT07170150
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-06-07
Contact for this trial
Reference Study ID Number: WN45447 https://forpatients.roche.com/