A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
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|ClinicalTrials.gov Identifier: NCT04592341|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Gantenerumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease|
|Actual Study Start Date :||November 18, 2020|
|Estimated Primary Completion Date :||October 27, 2023|
|Estimated Study Completion Date :||February 16, 2024|
Participants will receive gantenerumab by subcutaneous (SC) injection at a dose of 120 mg every 4 weeks (Q4W) for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg every 2 weeks (Q2W) for another 12 weeks, followed by the target dose 255 mg once weekly (Q1W) for up to Week 103.
Gantenerumab will be administered by SC injection at a dose of 120 mg Q4W for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg Q2W for another 12 weeks, followed by the target dose 255 mg Q1W for up to Week 103.
- Change from Baseline in Deposited Amyloid as Measured by Brain Amyloid PET Centiloid (CL) Levels [ Time Frame: Up to Week 104 ]
- Responses to home administration questionnaire [ Time Frame: Up to Week 104 ]The home administration questionnaire will capture confidence, ease of use, convenience, and overall satisfaction.
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 104 ]
- Change in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Up to Week 104 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 104 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 104 ]
- Percentage of Participants with Injection-Site Reactions (IRS) [ Time Frame: 24 hours after study drug administration, up to Week 104 ]Injection reactions (local and systemic) are defined as adverse events that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
- Percentage of Participants with Anti-Drug Antibodies to Gantenerumab [ Time Frame: Up to Week 104 ]
- Plasma Concentration of SC Gantenerumab at specified timepoints [ Time Frame: Up to Week 104 ]
- Change in Brain Amyloid Based on Different Dosing Frequency [ Time Frame: Up to Week 104 ]
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): NCT04592341
|Contact: Reference Study ID Number: WN29722 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||firstname.lastname@example.org|
|Study Director:||Clinical Trials||Hoffmann-La Roche|