Clinical trial NCT04339413: A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Official title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.


Eligibility criteria: Inclusion Criteria:

* Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
* Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
* For Part 1 and Part 2:
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
* Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
* Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant

Exclusion Criteria:

* Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
* Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
* If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
* Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
* Pregnancy
* Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
* Evidence of intracerebral macrohemorrhage
* Part 2: Participants who have been discontinued from Part 1 of the study

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
measure: Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (Day 1), up to Week 104
measure: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs
timeFrame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
measure: Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs
timeFrame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
measure: Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
timeFrame: Up to Week 133
measure: Number of Participants With Injection-Site Reactions
timeFrame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
measure: Number of Participants Who Discontinued Treatment Due to AEs
timeFrame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Insitute
state: Arizona
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Orlando
country: United States
facility: Accelerated Enrollment Solutions
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: The Villages
country: United States
facility: Bioclinica The Villages
state: Florida
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
state: Michigan
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Matthews
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Cordova
country: United States
facility: Neurology Clinic PC
state: Tennessee
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Neurologia Bs As
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital; Neurology
state: South Australia
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
state: Victoria
city: Halifax
country: Canada
facility: Centricity Research
state: Nova Scotia
city: Halifax
country: Canada
facility: True North Clinical Research-Halifax
state: Nova Scotia
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Santiago
country: Chile
facility: Especialidades Medicas LYS
city: København Ø
country: Denmark
facility: Rigshospitalet, Hukommelsesklinikken
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
state: Emilia-Romagna
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
state: Lombardia
city: Brescia
country: Italy
facility: IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
state: Lombardia
city: Castellanza
country: Italy
facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
state: Lombardia
city: Chiba
country: Japan
facility: Medical Corporation Hakuyokai Kashiwado Hospital
city: Chiba
country: Japan
facility: Juntendo University Urayasu Hospital; Neurology
city: Hiroshima
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital (Seoul)
city: Guadalajara
country: Mexico
facility: Hospital Mexico Americano
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Hospital Universitario; Dr. Jose E. Gonzalez
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
state: Nuevo LEON
city: Amsterdam
country: Netherlands
facility: Brain Research Center B.V
city: Pozna?
country: Poland
facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna PROSEN
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist
state: Sankt Petersburg
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Neurología
state: Alicante
city: Terrassa
country: Spain
facility: Hospital Mutua De Terrasa; Servicio de Neurologia
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Fundación ACE; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Neurologia
city: Basel
country: Switzerland
facility: Felix Platter-Spital Medizin Geriatrie
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine; Neurology
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medicine Faculty; Noroloji Departmani
city: Samsun
country: Turkey
facility: Ondokuz Mayis University School of Medicine; Neurology
city: Cardiff
country: United Kingdom
facility: Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
city: London
country: United Kingdom
facility: Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences
city: Newcastle
country: United Kingdom
facility: Campus for Ageing & Vitality; Clincal Ageing Research Unit
city: Warrington
country: United Kingdom
facility: Hollins Park Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: