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

CompletadoFase 3ClinicalTrials.gov

ID: NCT02051608Tipo: INTERVENTIONALInicio: 27 de mar de 2014Fin estimado: 16 de abr de 2021

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Resumen

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.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Placebo

Participants received Placebo SC injection Q4W.

drug

Gantenerumab

Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.

Ubicaciones

Instituto Neurologia Bs As

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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