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A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

NCT04592341•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Probable Alzheimer's Disease (AD) dementia or prodromal AD.
•Availability of a reliable study partner (non-professional caregiver) who accepts to participate in study procedure throughout the study duration
•The participant should be capable of completing all aspects of study assessments including MRI, clinical genotyping, and PET imaging, either alone or with the help of the study partner (non-professional caregiver).
•Adequate visual and auditory acuitysufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted).
•Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory.
•Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination (MMSE) score \>/=22 and Clinical Dementia Rating global score (CDR-GS) of 0.5 or 1.0, as well as a clinical dementia rating (CDR) memory domain score \>/=0.5.
•If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment.
•Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug.
•Agreement not to participate in other research studies for the duration of this trial, unless these are related Roche-sponsored non-interventional studies.
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods hat result in a failure rate of \< 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug.

Exclusion Criteria

•Any evidence of a condition other than AD that may affect cognition.
•History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function.
•History or presence of clinically evident cerebrovascular disease.
•History or presence of posterior reversible encephalopathy syndrome.
•History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack.
•History of severe, clinically significant CNS trauma.
•History or presence of intracranial mass that could potentially impair cognition.
•Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae.
•History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits.
•History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder.
+2 more criteria

Locations (34)

JEM Research LLC

Atlantis, Florida, United States

ClinCloud, LLC

Maitland, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Alzheimer?s Research and Treatment Center

Wellington, Florida, United States

Center for Advanced Research & Education

Gainesville, Georgia, United States

Summit Research Network Inc.

Portland, Oregon, United States

Abington Neurological Associates Willow Grove

Willow Grove, Pennsylvania, United States

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Key Dates

Start Date

November 18, 2020

Primary Completion Date

January 11, 2023

Completion Date

March 15, 2023

Last Updated

March 27, 2024

Enrollment

192

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Gantenerumab

DRUG

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Depressive SymptomsDepression+2 more

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RECRUITINGNA

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Alzheimer DiseaseLymphatic Obstruction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Inclusion Criteria

Exclusion Criteria

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