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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


Brief 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.


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

– 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


  • ATP Clinical Research, Inc, Costa Mesa, California, United States, 92626
  • Pacific Research Network – PRN, San Diego, California, United States, 92103
  • California Neuroscience Research Medical Group, Inc, Sherman Oaks, California, United States, 91403
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