Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03443973 |
Recruitment Status :
Recruiting
First Posted : February 23, 2018
Last Update Posted : January 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: Gantenerumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 760 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease |
Actual Study Start Date : | June 6, 2018 |
Estimated Primary Completion Date : | May 31, 2022 |
Estimated Study Completion Date : | May 2, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Gantenerumab
Gantenerumab will be administered as SC injections with gradual uptitration.
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Drug: Gantenerumab
Gantenerumab will be administered as per the schedule specified in the respective arm.
Other Name: RO4909832 |
Placebo Comparator: Placebo
Placebo will be administered as SC injections with gradual uptitration.
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Drug: Placebo
Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm. |
- Change From Baseline to Week 104 in Global Outcome, as Measured by Clinical Dementia Rating−Sum of Boxes (CDR-SOB) [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline to Week 104 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Subscale Score [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline to Week 104 in Mini-Mental State Examination (MMSE) Total Score [ Time Frame: Baseline up to Week 104 ]
- Change from Baseline to Week 104 in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline to Week 104 in Verbal Fluency Task Score [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline to Week 104 in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline to Week 104 ]
- Change From Baseline to Week 104 in Coding [ Time Frame: Change from baseline to Week 104 in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) coding subtest. ]
- Change From Baseline to Week 104 in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Total Score [ Time Frame: Baseline up to Week 104 ]
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to end of study (up to Week 152) ]
- Percentage of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab [ Time Frame: Baseline up to end of study (up to Week 152) ]
- Plasma Concentration of Gantenerumab [ Time Frame: Pre-dose (0 hour [hr]) at Baseline (Day 1), Weeks 24, 52, 76; and at Weeks 2, 41, 103, 116, 152, early termination visit ]
- Change from Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a subset of patients up to Week 104 [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Patients up to Week 104 [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline in Cerebral Spinal Fluid (CSF) Marker of Disease in a Subset of Patients - Amyloid-beta 1−42 (Aβ1−42) up to Week 104 [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline in CSF Marker of Disease in a Subset of Patients - Total Tau up to Week 104 [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline in CSF Marker of Disease in a Subset of Patients - Phosphorylated Tau up to Week 104 [ Time Frame: Baseline up to Week 104 ]
- Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI) up to Week 104 [ Time Frame: Baseline up to Week 104 ]MRI will be used to assess the effect of treatment on volume of whole brain, ventricles, hippocampus, or other structures.
- Change from Baseline to Week 104 in Instrumental Score [ Time Frame: Baseline Up to Week 104 ]

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Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment [MCI])
- Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan
- Demonstrated abnormal memory function
- MMSE score great than or equal to 22 (≥ 22)
- Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
- Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study
- If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to baseline and until randomization.
- For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry.
Key Exclusion Criteria:
- Any evidence of a condition other than AD that may affect cognition
- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
- History or presence of clinically evident cerebrovascular disease
- At risk for suicide in the opinion of the investigator
- Patients with evidence of folic acid deficiency
- Alcohol and/or substance abuse or dependants in past 2 years
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- Any contraindications to brain MRI
- Unstable or clinically significant cardiovascular, kidney or liver disease
- Uncontrolled hypertension

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443973
Contact: Reference Study ID Number: WN39658 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |

Study Director: | Clinical Trials | Hoffmann-La Roche |
Additional Information:
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03443973 History of Changes |
Other Study ID Numbers: |
WN39658 2017-001365-24 ( EudraCT Number ) |
First Posted: | February 23, 2018 Key Record Dates |
Last Update Posted: | January 10, 2019 |
Last Verified: | January 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |