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-GB
- 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
- 1463
• 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 and lumbar puncture [if applicable]).
• 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
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 characterize the pharmacokinetic (PK) profile of gantenerumab administered by SC injection<br>• To evaluate the immune response to gantenerumab administered by SC injection<br>• To evaluate the long-term effects of gantenerumab on fluid and image based biomarkers administered by SC injection<br>;Primary end point(s): 1. Nature, frequency, severity, and timing of adverse events and serious adverse events<br>2. Physical examinations (including neurologic systems), vital signs, blood 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, and timing of ISRs<br>;Timepoint(s) of evaluation of this end point: 1-4. 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>PK<br>8. Plasma concentration of gantenerumab administered SC at specified timepoints<br><br>Immunogenicity<br>9. 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>8-9. Up to Week 116<br>