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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

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

ArmDescriptionAssigned Intervention
Experimental
Trontinemab 		Participants will receive intravenous (IV) trontinemab.
  • Drug: Trontinemab
    Participants will receive IV trontinemab.
    Other names:
    • RO7126209
Placebo Comparator
Placebo 		Participants will receive IV placebo.
  • Other: Placebo
    Participants will receive IV placebo.

Recruiting Locations

Banner Sun Health Research Institute
Sun City, Arizona 85351

Inglewood Clinicals
Inglewood, California 90301

Irvine Center for Clinical Research
Irvine, California 92614

UCSF - Memory and Aging Center
San Francisco, California 94158

Syrentis Clinical Research
Santa Ana, California 92705

K2 Medical Research - The Villages
Lady Lake, Florida 32159

K2 Medical Research, LLC
Maitland, Florida 32751

Renstar Medical Research
Ocala, Florida 34470

Axiom Brain Health LLC
Tampa, Florida 33609

Charter Research - Lady Lake/The Villages
The Villages, Florida 32162

Alzheimer?s Research and Treatment Center
Wellington, Florida 33414

Conquest Research, LLC
Winter Park, Florida 32789

Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia 31904

Accel Research Sites-NeuroStudies
Decatur, Georgia 30030

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817

RE:Cognition (Chicago)
Chicago, Illinois 60611

Boston Center for Memory
Newton, Massachusetts 02459

Washington University School of Medicine
St Louis, Missouri 63110

The Cognitive and Research Center of New Jersey
Ridgewood, New Jersey 07450

Basil Clinical
Laurelton, New York 11413-2016

Weill Cornell Medical College
New York, New York 10021

Adams Clinical Harlem
New York, New York 10029

Adams Clinical Bronx
The Bronx, New York 10461

Triad Clinical Trials
Greensboro, North Carolina 27410

Butler Hospital
Providence, Rhode Island 02906

Genesis Neuroscience Clinic
Knoxville, Tennessee 37909

K2 Medical Research - Nashville
Nashville, Tennessee 37204

Kerwin Research Center, LLC
Dallas, Texas 75231

South Texas Research Institute - Edinburg
Edinburg, Texas 78539

Re:Cognition Health - Houston
Houston, Texas 77030

National Clinical Research Inc.-Richmond
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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.