Trontinemab for Early Symptomatic Alzheimer's Disease
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Recruiting
Phase 3Interventional Study
Alzheimers Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
This trial is looking for people with early symptoms of Alzheimer's disease. Participants will take a medication called trontinemab and go through tests like imaging and assessments to see how well the treatment works and if it is safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am willing and able to complete all aspects of the study.
I have adequate vision and hearing to complete tests.
I have been diagnosed with early symptomatic Alzheimer's disease.
My score on the MMSE test is 22 or higher.
I have noticed a decline in my cognitive abilities over the last year.
I have a Repeatable Battery for the Assessment of Neuropsychological Status score of 85 or above.
I have a study partner available to help me.
You may not be able to join if
I have a condition other than Alzheimer's that affects my thinking.
I have a history of significant cerebrovascular disease.
I have had significant brain trauma in the past.
I have a clinically significant mass in my brain.
I cannot tolerate MRI procedures.
I have other medical conditions that are unstable.
I have a history of cancer, unless I am considered cured.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility 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…
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
Contacts
Reference Study ID Number: WN45447 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
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