Health Trials

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

ConditionAlzheimers Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-90
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trontinemab

    Drug

    Participants will receive IV trontinemab.

  • Placebo

    Other intervention

    Participants will receive IV placebo.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: TrontinemabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Time frame
Baseline - Week 72

Secondary outcomes

1

Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

Time frame
Baseline - Week 72
2

Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score

Time frame
Baseline - Week 72
3

Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame
Baseline - Week 72
4

Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)

Time frame
Baseline - Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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