A Clinical Trial 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 Alzheimer?s Institute
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Sun Valley Research Center, Inc.
Imperial, California 92251
Imperial, California 92251
Healthy Brain Clinic
Long Beach, California 90804
Long Beach, California 90804
Oakland Clinical
Oakland, California 94609
Oakland, California 94609
Riverside Clinical
Riverside, California 92506
Riverside, California 92506
Cenexel California Neuroscience Research, LLC
Sherman Oaks, California 91403
Sherman Oaks, California 91403
Yale University
New Haven, Connecticut 06510
New Haven, Connecticut 06510
JEM Research LLC
Atlantis, Florida 33462
Atlantis, Florida 33462
K2 Medical Research-Winter Garden
Clermont, Florida 34711
Clermont, Florida 34711
Visionary Investigators Network- Neurology Aventura
Miami, Florida 33133
Miami, Florida 33133
Charter Research - Winter Park/Orlando
Orlando, Florida 32803
Orlando, Florida 32803
Conquest Research - Lake Nona
Orlando, Florida 32832
Orlando, Florida 32832
Alzheimer's Research and Treatment Center
Stuart, Florida 34997
Stuart, Florida 34997
CenExel iResearch, LLC
Decatur, Georgia 30030
Decatur, Georgia 30030
Center for Advanced Research & Education
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois 60640
Chicago, Illinois 60640
Adams Clinical Boston
Boston, Massachusetts 02116
Boston, Massachusetts 02116
Adams Clinical Watertown
Watertown, Massachusetts 02472
Watertown, Massachusetts 02472
Quest Research Institute
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
University of Nebraska Medical Center
Omaha, Nebraska 68198-8440
Omaha, Nebraska 68198-8440
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
Springfield, New Jersey 07081
AD-CARE, University of Rochester Medical Center
Rochester, New York 14620
Rochester, New York 14620
Summit Research Network Inc.
Portland, Oregon 97210
Portland, Oregon 97210
Flourish Research ? Philadelphia
Plymouth Meeting, Pennsylvania 19462
Plymouth Meeting, Pennsylvania 19462
Gadolin Research, LLC
Beaumont, Texas 77702
Beaumont, Texas 77702
Kerwin Medical Center
Dallas, Texas 75216
Dallas, Texas 75216
Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Mt.Olympus Medical Research
Katy, Texas 77450
Katy, Texas 77450
El Faro Health and Therapeutics
Rio Grande City, Texas 78582
Rio Grande City, Texas 78582
Sana Research, LLC
Arlington, Virginia 22205
Arlington, Virginia 22205
Re:Cognition Health
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Hoffmann-La Roche
Study Contact
Reference Study ID Number: WN45447 https://forpatients.roche.com/888-662-6728
global-roche-genentech-trials@gene.com