A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants with Alzheimer's Disease
- Conditions
- Alzheimer's DiseaseMedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10074616Term: Prodromal Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-000766-42-NL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2032
• Completed Study WN29922 or WN39658, either its double-blind part (participants have reached the 510 mg Q2W dose schedule by the time of completion) or OLE part (participants have received at least 3 doses of 510 mg Q4W), and did not discontinue study drug early
• Ability to comply with the study protocol
• Willingness and ability to complete all aspects of the study (including MRI).
• Availability of a caregiver
• The participant should be capable of completing assessments either alone or with the help of the caregiver
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 16 weeks after the
final dose of gantenerumab
• Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1170
• Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
• Prematurely discontinued from Study WN29922 or WN39658, either its double-blind or OLE part, as applicable, or from study drug, for any reason
• Any medical condition that the investigator or Sponsor determines may jeopardize the participant’s safety if he or she continues to receive study treatment
• Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part, as applicable
• Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
• Evidence of intracerebral macrohemorrhage
• Use of prohibited medication
• Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the safety and tolerability of long-term gantenerumab administered by SC injection;Secondary Objective: • To evaluate the efficacy of long-term gantenerumab administered by SC injection<br>• To evaluate the immune response to gantenerumab administered by SC injection;Primary end point(s): 1. Nature, frequency, severity, timing, and outcomes of adverse events and serious adverse events<br>2. Physical examinations (including neurologic systems), vital signs, ECG, laboratory tests, and Columbia-Suicide Severity Rating Scale (C-SSRS)<br>3. Nature, frequency, severity, and timing of ARIA-E and ARIA-H<br>4. Nature, frequency, severity, timing, and outcomes of ISRs<br>5. Incidence of treatment discontinuations for adverse events<br>6. Incidence of adverse events of special interest;Timepoint(s) of evaluation of this end point: 1-6. Up to Week 116
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy<br>1. Change over time in Clinical Dementia Rating (CDR)<br>2. Change over time in Mini-Mental State Examination (MMSE)<br>3. Change over time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADASCog13) and Subscale 11 (ADAS-Cog11) <br>4. Change over time in Verbal Fluency Task<br>5. Change over time in Coding<br>6 Change over time in Functional Activities Questionnaire (FAQ)<br>7. Change over time in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)<br><br>Immunogenicity<br>8. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study<br>;Timepoint(s) of evaluation of this end point: 1-7. Baseline to Week 104<br>8. Up to Week 116<br>