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 : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : September 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Gantenerumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 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 :||July 27, 2023|
|Estimated Study Completion Date :||November 13, 2025|
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. Participants who complete Week 104 visit will be given an option to take part in 2-year extension of the study to receive gantenerumab 255 mg Q1W for up to Week 207.
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 and an optional dose of 255 mg Q1W for up to Week 207.
- 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 208 ]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 224 ]
- Change in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Up to Week 208 ]The C-SSRS is an assessment tool used to assess the lifetime suicidality of a patient (C-SSRS at baseline) as well as any new instances of suicidality (C-SSRS since last visit). The structured interview prompts recollection of suicidal ideation, including the intensity of the ideation, behavior, and attempts with actual or potential lethality.
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 208 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 208 ]
- Percentage of Participants with Injection-Site Reactions (ISR) [ Time Frame: 24 hours after study drug administration, up to Week 208 ]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 224 ]
- Plasma Concentration of SC Gantenerumab at specified timepoints [ Time Frame: Up to Week 224 ]
- Change in Brain Amyloid Based on Different Dosing Frequency [ Time Frame: Up to Week 208 ]
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
|Study Director:||Clinical Trials||Hoffmann-La Roche|