A Study of Gantenerumab in Participants With Mild Alzheimer Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 50 - 90 |
Updated: | 2/2/2019 |
Start Date: | March 27, 2014 |
End Date: | November 20, 2020 |
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
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.
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
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
We found this trial at
38
sites
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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1000 Oakland Drive
Kalamazoo, Michigan 49008
Kalamazoo, Michigan 49008
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