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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 Alzheimer?s Institute
Phoenix 5308655, Arizona 5551752 85006

Healthy Brain Clinic
Long Beach 5367929, California 5332921 90804

Oakland Clinical
Oakland 5378538, California 5332921 94609

Riverside Clinical
Riverside 5387877, California 5332921 92506

Cenexel California Neuroscience Research, LLC
Sherman Oaks 5395244, California 5332921 91403

Yale University
New Haven 4839366, Connecticut 4831725 06510

JEM Research LLC
Atlantis 4146372, Florida 4155751 33462

K2 Medical Research-Winter Garden
Clermont 4151352, Florida 4155751 34711

Visionary Investigators Network- Neurology Aventura
Miami 4164138, Florida 4155751 33133

Charter Research - Winter Park/Orlando
Orlando 4167147, Florida 4155751 32803

Conquest Research - Lake Nona
Orlando 4167147, Florida 4155751 32832

Alzheimer's Research and Treatment Center
Stuart 4174201, Florida 4155751 34997

CenExel iResearch, LLC
Decatur 4191124, Georgia 4197000 30030

Center for Advanced Research & Education
Gainesville 4196586, Georgia 4197000 30501

Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago 4887398, Illinois 4896861 60640

Adams Clinical Watertown
Watertown 4954611, Massachusetts 6254926 02472

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198-8440

The Cognitive and Research Center of New Jersey
Springfield 5104952, New Jersey 5101760 07081

AD-CARE, University of Rochester Medical Center
Rochester 5134086, New York 5128638 14620

Summit Research Network Inc.
Portland 5746545, Oregon 5744337 97210

Flourish Research ? Philadelphia
Plymouth Meeting 5206666, Pennsylvania 6254927 19462

Gadolin Research, LLC
Beaumont 4672989, Texas 4736286 77702

Kerwin Medical Center
Dallas 4684888, Texas 4736286 75216

Re:Cognition Health - Fort Worth
Fort Worth 4691930, Texas 4736286 76104

Mt.Olympus Medical Research
Katy 4702732, Texas 4736286 77450

Sana Research, LLC
Arlington 4744709, Virginia 6254928 22205

Re:Cognition Health
Fairfax 4758023, Virginia 6254928 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

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.