A Study of Gantenerumab in Participants With Mild Alzheimer Disease
- Neurodegenerative Disorder
- Alzheimer's Disease (AD)
Completed
- Aarhus
- Abington
- Adelaide
- Amadora
- Amsterdam
- Austin
- Baggiovara
- Barakaldo
- Barcelona
- Basel
- Baton Rouge
- Berlin
- Bordeaux
- Brescia
- Bron
- Brooksville
- Bruxelles
- Budapest
- Buenos Aires
- Burlington
- Busan
- Calgary
- Castellanza
- Chiba
- Costa Mesa
- Crowborough
- Delray Beach
- East Providence
- Elche
- Fort Myers
- Fukuoka
- Gatineau
- Glasgow
- Halifax
- Himeji
- Incheon
- Indianapolis
- İstanbul
- ivanhoe
- İzmir
- Kalamazoo
- Kamakura
- Kazan
- Kuopio
- Kurashiki
- København
- lakehurst
- Lausanne
- Leipzig
- Leuven
- Limoges
- Lisboa
- London
- Longueuil
- Los Angeles
- Madrid
- Manchester
- Marseille
- matthews
- Memphis
- Miami
- Mittweida
- Montréal
- Monza
- Moscow
- München
- Nedlands
- New Orleans
- New York
- Orangeburg
- Orlando
- Otake
- Peterborough
- Pisa
- Plains
- Preston
- Québec
- Raleigh
- Rennes
- Roma
- Rotterdam
- Saint Petersburg
- Salt Lake City
- Samsun
- San Diego
- San Sebastián
- Sankt-Peterburg
- Saratov
- Seongnam-si
- Seoul
- Sevilla
- Sheffield
- Shizuoka
- Skåne län
- Sofia
- St. Louis
- Stockholms län
- Strasbourg
- Sun City
- Tampa
- Toms River
- Toronto
- Toulouse
- Tucson
- Tulsa
- Turku
- Ulm
- Urayasu
- València
- Varna
- Wellington
- Westerstede
- Woodville South
- Yufu
NCT02051608 2013-003390-95 WN28745
Trial 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.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
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
For the latest version of this information please go to www.forpatients.roche.com