A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Purpose
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).
Condition
- Alzheimers Disease
Eligibility
- Eligible Ages
- Between 50 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Trontinemab |
Participants will receive intravenous (IV) trontinemab. |
|
|
Placebo Comparator Placebo |
Participants will receive IV placebo. |
|
Recruiting Locations
Banner Sun Health Research Institute
Sun City, Arizona 85351
Sun City, Arizona 85351
Inglewood Clinicals
Inglewood, California 90301
Inglewood, California 90301
Irvine Center for Clinical Research
Irvine, California 92614
Irvine, California 92614
UCSF - Memory and Aging Center
San Francisco, California 94158
San Francisco, California 94158
Syrentis Clinical Research
Santa Ana, California 92705
Santa Ana, California 92705
K2 Medical Research - The Villages
Lady Lake, Florida 32159
Lady Lake, Florida 32159
K2 Medical Research, LLC
Maitland, Florida 32751
Maitland, Florida 32751
Renstar Medical Research
Ocala, Florida 34470
Ocala, Florida 34470
Axiom Brain Health LLC
Tampa, Florida 33609
Tampa, Florida 33609
Charter Research - Lady Lake/The Villages
The Villages, Florida 32162
The Villages, Florida 32162
Alzheimer?s Research and Treatment Center
Wellington, Florida 33414
Wellington, Florida 33414
Conquest Research, LLC
Winter Park, Florida 32789
Winter Park, Florida 32789
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia 31904
Columbus, Georgia 31904
Accel Research Sites-NeuroStudies
Decatur, Georgia 30030
Decatur, Georgia 30030
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
RE:Cognition (Chicago)
Chicago, Illinois 60611
Chicago, Illinois 60611
Boston Center for Memory
Newton, Massachusetts 02459
Newton, Massachusetts 02459
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
The Cognitive and Research Center of New Jersey
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
Basil Clinical
Laurelton, New York 11413-2016
Laurelton, New York 11413-2016
Weill Cornell Medical College
New York, New York 10021
New York, New York 10021
Adams Clinical Harlem
New York, New York 10029
New York, New York 10029
Adams Clinical Bronx
The Bronx, New York 10461
The Bronx, New York 10461
Triad Clinical Trials
Greensboro, North Carolina 27410
Greensboro, North Carolina 27410
Butler Hospital
Providence, Rhode Island 02906
Providence, Rhode Island 02906
Genesis Neuroscience Clinic
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
K2 Medical Research - Nashville
Nashville, Tennessee 37204
Nashville, Tennessee 37204
Kerwin Research Center, LLC
Dallas, Texas 75231
Dallas, Texas 75231
South Texas Research Institute - Edinburg
Edinburg, Texas 78539
Edinburg, Texas 78539
Re:Cognition Health - Houston
Houston, Texas 77030
Houston, Texas 77030
National Clinical Research Inc.-Richmond
Richmond, Virginia 23294
Richmond, Virginia 23294
More Details
- Status
- Recruiting
- Sponsor
- Hoffmann-La Roche
Study Contact
Reference Study ID Number: WN45443 https://forpatients.roche.com/888-662-6728
global-roche-genentech-trials@gene.com