A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Recruiting · NCT07170150 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTrontinemab
What this trial is about
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 take part
Age range
50 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 17 US states.
- Banner Alzheimer?s Institute - Phoenix, Arizona, United States
- Sun Valley Research Center, Inc. - Imperial, California, United States
- Healthy Brain Clinic - Long Beach, California, United States
- Oakland Clinical - Oakland, California, United States
- Riverside Clinical - Riverside, California, United States
- Cenexel California Neuroscience Research, LLC - Sherman Oaks, California, United States
- Yale University - New Haven, Connecticut, United States
- JEM Research LLC - Atlantis, Florida, United States
- K2 Medical Research-Winter Garden - Clermont, Florida, United States
- Visionary Investigators Network- Neurology Aventura - Miami, Florida, United States
- Charter Research - Winter Park/Orlando - Orlando, Florida, United States
- Conquest Research - Lake Nona - Orlando, Florida, United States
- Alzheimer's Research and Treatment Center - Stuart, Florida, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Center for Advanced Research & Education - Gainesville, Georgia, United States
- Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville - Chicago, Illinois, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- Quest Research Institute - Farmington Hills, Michigan, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- The Cognitive and Research Center of New Jersey - Springfield, New Jersey, United States
- IMA Clinical Research - Albuquerque - Albuquerque, New Mexico, United States
- AD-CARE, University of Rochester Medical Center - Rochester, New York, United States
- Summit Research Network Inc. - Portland, Oregon, United States
- Flourish Research ? Philadelphia - Plymouth Meeting, Pennsylvania, United States
- Palmetto Clinical Trials - Summerville, South Carolina, United States
- Gadolin Research, LLC - Beaumont, Texas, United States
- Kerwin Medical Center - Dallas, Texas, United States
- Re:Cognition Health - Fort Worth - Fort Worth, Texas, United States
- Mt.Olympus Medical Research - Katy, Texas, United States
- El Faro Health and Therapeutics - Rio Grande City, Texas, United States
- Sana Research, LLC - Arlington, Virginia, United States
- Re:Cognition Health - Fairfax, Virginia, United States
- Brain Research Center Den Bosch - 's-Hertogenbosch, Netherlands
- O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie - ?cinawa, Poland
- ProNeuro Centrum Medyczne - ?ory, Poland
- Uniwersytet Medyczny w Lodzi - ?ód?, Poland
- Aalborg Universitetshospital - Aalborg, Denmark
- Aarhus Universitetshospital Skejby - Aarhus N, Denmark
- CHU Amiens Hopital Sud - Amiens Cedex1, France
- Brain Research Center B.V - Amsterdam, Netherlands
- Syberka-ClinHouse Sp. z o.o. - B?dzin, Poland
- Fundación ACE - Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- ReMind UK - Bath, United Kingdom
- Ambulates Gesundheitszentrum der Charité GmbH - Berlin, Germany
- ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic - Berlin, Germany
- Inselspital Bern Medizin Neurologie - Bern, Switzerland
- Podlaskie Centrum Psychogeriatrii - Bia?ystok, Poland
- Re:Cognition Health Birmingham - Birmingham, United Kingdom
- German Center for Neurodegenerative Diseases (DZNE) - Bonn, Germany
- Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin - Bordeaux, France
- Groupement Hospitalier Est - Hôpital Neurologique - Bron, France
- Pusan National University Hospital - Busan, South Korea
- CIER - C. A. B. A., Argentina
- Universitätsklinikum Köln - Cologne, Germany
- Medizinische Fakultät Carl Gustav Carus - Dresden, Germany
- Scottish Brain Sciences - Edinburgh, United Kingdom
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Hôpitaux universitaires de Genève - Geneva, Switzerland
Showing 60 of 150 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →