Select Your Region
Global
A Study of Gantenerumab in Participants With Mild Alzheimer Disease
- Neurodegenerative Disorder
- Alzheimer's Disease (AD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- 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
Trial Identifier:
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02051608, WN28745, 2013-003390-95
Trial Identifier
Gantenerumab, Placebo
Treatments
Alzheimer's Disease
Condition
Official Title
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
All
Gender
≥50 Years & ≤ 90 Years
Age
No
Healthy Volunteers
Inclusion 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
Exclusion Criteria
- 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