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- Marguerite RoAD
A Study of Gantenerumab in Participants With Mild Alzheimer Disease
Neurodegenerative Disorder Alzheimer's Disease (AD)
Basic Details
Study Summary
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
Eligibility Criteria
- Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
- Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
- Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
- Fluency in the language of the tests used at the study site
- Willingness and ability to complete all aspects of the study
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
- Agreement not to participate in other research studies for the duration of this trial and its associated substudies
PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2
- Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
- History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
- History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
- History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
- History of schizophrenia, schizoaffective disorder, or bipolar disorder
- Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
- History or presence of atrial fibrillation
- Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
- Uncontrolled hypertension
- Chronic kidney disease
- Impaired hepatic function
PET imaging substudy, in addition to above:
- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
Part 2 Participants who have been discontinued from the study
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS WN28745 Marguerite RoAD final results April 2022 English
(PDF, 1.2 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Belgium Dutch
(PDF, 0.5 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Belgium French
(PDF, 0.5 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Denmark
(PDF, 0.9 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Finland
(PDF, 0.4 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Italy
(PDF, 0.8 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Spain
(PDF, 0.6 MB)
LPS WN28745 Marguerite RoAD final results April 2022 Japan
(PDF, 0.6 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Argentina
(PDF, 0.6 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Netherlands
(PDF, 1.0 MB)
LPS WN28745 Marguerite RoAD final results June 2022 Sweden
(PDF, 0.4 MB)
LPS WN28745 Marguerite RoAD final results February 2022 Canada French
(PDF, 0.6 MB)
LPS WN28745 Marguerite RoAD final results April 2022 Hungary
(PDF, 0.8 MB)
LPS WN28745 Marguerite RoAD final results April 2022 Korean
(PDF, 0.8 MB)
LPS WN28745 Marguerite RoAD Final Results April 2022 Brazil Portuguese
(PDF, 0.5 MB)
LPS WN28745 Marguerite RoAD Final Results April 2022 Turkey Turkish
(PDF, 0.7 MB)
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For the latest version of this information please go to www.forpatients.roche.com