Recruiting NCT07169578

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Phase III Interventional Alzheimers Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Trontinemab, Placebo.
Who it may be relevant to: Registry conditions: Alzheimers Disease. Basic parameters: 50 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Canada, China +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

Overview

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).

Interventions

Drug Trontinemab
Participants will receive IV trontinemab.
Other Placebo
Participants will receive IV placebo.

Primary outcome measures

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [Time frame: Baseline - Week 72]

Secondary outcome measures (12)

Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) [Time frame: Baseline - Week 72]
Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score [Time frame: Baseline - Week 72]
Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) [Time frame: Baseline - Week 72]
Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) [Time frame: Baseline - Week 72]
Change from baseline in CDR-SB [Time frame: Baseline up to but excluding Week 72]
Time to increase in Clinical Dementia Rating, Global Score (CDR-GS) [Time frame: Baseline - Week 72]
Percentage of participants with adverse events (AEs) [Time frame: Baseline - Week 72]
Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings [Time frame: Baseline - Week 72]
Percentage of participants with infusion-related reactions (IRR) [Time frame: Baseline - Week 72]
Percentage of participants with anti-drug antibodies (ADAs) to trontinemab [Time frame: Baseline - Week 72]
Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan [Time frame: Baseline - Week 72]
Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants [Time frame: Baseline - Week 72]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 35 centers

University of Alabama at Birmingham — Birmingham
Banner Sun Health Research Institute — Sun City
Irvine Center for Clinical Research — Irvine
Inglewood Clinicals — Los Angeles
UCSF - Memory and Aging Center — San Francisco
Syrentis Clinical Research — Santa Ana
K2 Medical Research - The Villages — Lady Lake
K2 Medical Research, LLC — Maitland
… and 27 more centers

China · 25 centers

The Affiliated Hospital of Xuzhou Medical University — Xuzhou
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
Peking University First Hospital — Beijing
Beijing Friendship Hospital Affiliated of Capital University of Medical Science — Beijing
Beijing Tiantan Hospital,Capital Medical University — Beijing
Peking University Sixth Hospital — Beijing
The First Hospital of Jilin University — Changchun
West China Hospital - Sichuan University — Chengdu
… and 17 more centers

Germany · 13 centers