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A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04339413
Collaborator
(none)
116
Enrollment
56
Locations
1
Arm
60.2
Anticipated Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicenter, rollover study 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 will be eligible to participate in Part 1 of this study. Of these, participants who complete Week 104 visit in Part 1 will be eligible for Part 2 of this study. Participants will continue receiving 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 (part 2).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 22, 2020
Anticipated Primary Completion Date :
May 27, 2025
Anticipated Study Completion Date :
May 27, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gantenerumab

Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) up to Week 208.

Drug: Gantenerumab
Gantenerumab will be administered as SC injection Q4W

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212)]

  2. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [Baseline (Day 1) up to Week 208]

  3. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [Baseline (Day 1) up to Week 208]

  4. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [Baseline (Day 1) up to Week 208]

  5. Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab [Baseline (Day 1) up to Week 208]

  6. Percentage of Participants with Injection-Site Reactions [Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212)]

  7. Percentage of Participants Who Discontinued Treatment due to AEs [Baseline (Day 1) up to Week 208]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner Sun Health Research Insitute Sun City Arizona United States 85351
2 California Neuroscience Research Medical Group, Inc Sherman Oaks California United States 91403
3 Accelerated Enrollment Solutions Orlando Florida United States 32806
4 University of South Florida Tampa Florida United States 33613-4706
5 Bioclinica The Villages The Villages Florida United States 32162
6 Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research Kalamazoo Michigan United States 49008
7 Richmond Behavioral Associates Staten Island New York United States 10312
8 Alzheimer's Memory Center Matthews North Carolina United States 28105
9 Central States Research Tulsa Oklahoma United States 74136
10 Neurology Clinic PC Cordova Tennessee United States 38018
11 Senior Adults Specialty Research Austin Texas United States 78757
12 Instituto Neurologia Bs As Ciudad Autonoma Buenos Aires Argentina C1426ANZ
13 The Queen Elizabeth Hospital; Neurology Woodville South Australia Australia 5011
14 Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Heidelberg West Victoria Australia 3081
15 True North Clinical Research-Halifax Halifax Nova Scotia Canada B3S 1N2
16 True North Clinical Research New Minas Nova Scotia Canada B4N 3R7
17 Kawartha Centre - Redefining Healthy Aging Peterborough Ontario Canada K9H 2P4
18 Toronto Memory Program Toronto Ontario Canada M3B 2S7
19 Alpha Recherche Clinique Quebec Canada G3K 2P8
20 Especialidades Medicas LYS Santiago Chile 7560356
21 Rigshospitalet, Hukommelsesklinikken Koebenhavn Oe Denmark 2100
22 Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze Modena Emilia-Romagna Italy 41126
23 Azienda Ospedaliera Spedali Civili; Scienze Neurologiche Brescia Lombardia Italy 25100
24 IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer Brescia Lombardia Italy 25125
25 Irccs Multimedica Santa Maria; Unita' Di Neurologia Castellanza Lombardia Italy 21053
26 Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia Milano Lombardia Italy 20132
27 Medical Corporation Hakuyokai Kashiwado Hospital Chiba Japan 260-8656
28 Juntendo University Urayasu Hospital; Neurology Chiba Japan 279-0021
29 National Hospital Organization Hiroshima-Nishi Medical Center Hiroshima Japan 739-0696
30 Inha University Hospital Incheon Korea, Republic of 22332
31 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
32 Ewha Womans University Hospital (Seoul) Seoul Korea, Republic of 07804
33 Hospital Mexico Americano Guadalajara Mexico CITY (federal District) Mexico 44610
34 Hospital Universitario; Dr. Jose E. Gonzalez Monterrey Nuevo LEON Mexico 64460
35 AVIX Investigación Clínica S.C Monterrey Mexico 64710
36 Brain Research Center B.V Amsterdam Netherlands 1081 GN
37 NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek Poznań Poland 61-853
38 Przychodnia Specjalistyczna PROSEN Warszawa Poland 01-231
39 Centrum Medyczne NeuroProtect Warszawa Poland 01-684
40 Kirov State Medical Academy Kirov Russian Federation 610027
41 Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center Saint Petersburg Russian Federation 190103
42 Hospital General Universitario de Elche; Servicio de Neurología Elche Alicante Spain 03203
43 Hospital Mutua De Terrasa; Servicio de Neurologia Terrassa Barcelona Spain 08222
44 Hospital del Mar; Servicio de Neurologia Barcelona Spain 08003
45 Fundación ACE; Servicio de Neurología Barcelona Spain 08028
46 Hospital Universitario 12 de Octubre; Servicio de Neurologia Madrid Spain 28041
47 Hospital Universitario Dr. Peset; Servicio de Neurologia Valencia Spain 46017
48 Hospital Universitario la Fe; Servicio de Neurologia Valencia Spain 46026
49 Felix Platter-Spital Medizin Geriatrie Basel Switzerland 4002
50 Istanbul University Istanbul School of Medicine; Neurology Istanbul Turkey 34093
51 Dokuz Eylul University Medicine Faculty; Noroloji Departmani Izmir Turkey 35340
52 Ondokuz Mayis University School of Medicine; Neurology Samsun Turkey 55139
53 Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building Cardiff United Kingdom CF64 2XX
54 Charing Cross Hospital; Dept of Neurosciences London United Kingdom W6 8RF
55 Campus for Ageing & Vitality; Clincal Ageing Research Unit Newcastle United Kingdom NE4 5PL
56 Hollins Park Hospital Warrington United Kingdom WA2 8WA

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04339413
Other Study ID Numbers:
  • WN41874
First Posted:
Apr 9, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Mar 18, 2022