Trial Status: 
Open to Enrollment
Trial Eligibility: 

Inclusion Criteria:
   • Age between 50 and 90 years old
   • Have early symptoms of mild cognitive impairment or Alzheimer’s disease, or have already been diagnosed
   • Have a study partner that can come to the study visits for 18 months
   
Exclusion Criteria:
   • Evidence of a condition other than Alzheimer’s Disease that may affect cognition
   
Detailed eligibility criteria will be reviewed when contacting the study team.
   

Trial Description: 

The main purpose of this study is to investigate whether the study drug, trontinemab, is able to slow down the worsening of symptoms in participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. 

Trontinemab combines an anti-amyloid antibody with a module that helps deliver the antibody more efficiently to the brain. Once in the brain, trontinemab works by removing amyloid-beta plaques, a protein associated with Alzheimer’s disease.

The study will last about 18 months. The study assessments include physical examinations, clinical lab tests, brain scans, and memory tests. 

All participants in this study will be divided randomly into two equal groups: one group will receive trontinemab, while the other group will receive a placebo. 

The study drug, trontinemab, and the placebo will be given as infusions. Participants will receive monthly infusions into the vein every month for the first 6 months, then every 3 months thereafter. There will be a total of 15 study visits.

Primary Investigator: 
Sonja Blum, MD, PHD
Trial Location: 
Upper East Side - Manhattan
Drugs / Device: 
Drug
Protocol ID: 
2505028885
Study Type: 
Interventional
Sponsor: 
Roche
Trial Category: 
Alzheimer's Disease Mild Cognitive Impairment