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

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

Inglewood Clinicals
Inglewood 5359488, California 5332921 90301

Irvine Center for Clinical Research
Irvine 5359777, California 5332921 92614

Syrentis Clinical Research
Santa Ana 5392900, California 5332921 92705

K2 Medical Research - The Villages
Lady Lake 4161118, Florida 4155751 32159

K2 Medical Research, LLC
Maitland 4163220, Florida 4155751 32751

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470

Axiom Brain Health LLC
Tampa 4174757, Florida 4155751 33609

Charter Research - Lady Lake/The Villages
The Villages 4175179, Florida 4155751 32162

Alzheimer?s Research and Treatment Center
Wellington 4177703, Florida 4155751 33414

Conquest Research, LLC
Winter Park 4178560, Florida 4155751 32789

Accel Research Sites-NeuroStudies
Decatur 4191124, Georgia 4197000 30030

Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817

Boston Center for Memory
Newton 4945283, Massachusetts 6254926 02459

The Cognitive and Research Center of New Jersey
Ridgewood 5103269, New Jersey 5101760 07450

Basil Clinical
Laurelton 5124078, New York 5128638 11413-2016

Adams Clinical Harlem
New York 5128581, New York 5128638 10029

Triad Clinical Trials
Greensboro 4469146, North Carolina 4482348 27410

Kerwin Research Center, LLC
Dallas 4684888, Texas 4736286 75231

National Clinical Research Inc.-Richmond
Richmond 4781708, Virginia 6254928 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