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Monoclonal Antibodies

Gantenerumab for Alzheimer's Disease

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline [day 1] up to 4 weeks after the last dose of study drug (up to week 133)

Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a long-term administration of gantenerumab in people with Alzheimer's Disease. The study has two parts, and participants will receive gantenerumab by injection every four weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline [day 1] up to 4 weeks after the last dose of study drug (up to week 133)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline [day 1] up to 4 weeks after the last dose of study drug (up to week 133)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline [day 1] up to 4 weeks after the last dose of study drug (up to week 133) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Discontinued Treatment Due to AEs

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs

+4 more

Side effects data

From 2021 Phase 3 trial • 389 Patients • NCT02051608

27%

Injection site reaction

22%

ARIA-E

19%

ARIA-H

18%

Fall

12%

Nasopharyngitis

11%

Headache

Back pain

Agitation

Urinary tract infection

Dizziness

Constipation

Insomnia

Contusion

Arthralgia

Anxiety

Depression

Hypertension

Influenza

Vomiting

Diarrhoea

Skin abrasion

Rash

Nausea

Oedema peripheral

Bronchitis

Upper respiratory tract infection

Pyrexia

Arrhythmia

Femur fracture

Cardiac arrest

Acute coronary syndrome

Atrial fibrillation

Bradycardia

Cardiac failure acute

Myocardial infarction

Diverticulum intestinal haemorrhagic

Dysphagia

Gastrointestinal haemorrhage

Pancreatitis

Cyst

Pain

Cholelithiasis

Liver disorder

Anaphylactic shock

Cellulitis

Colonic abscess

Gastroenteritis rotavirus

Ankle fracture

Femoral neck fracture

Meniscus injury

Multiple fractures

Road traffic accident

Spinal compression fracture

Subdural haematoma

Upper limb fracture

Hypoglycaemia

Hyponatraemia

Bladder transitional cell carcinoma

Invasive lobular breast carcinoma

Brain stem infarction

Cerebral venous sinus thrombosis

Dementia Alzheimer's type

Epilepsy

Hydrocephalus

Leukoencephalopathy

Psychomotor hyperactivity

Vertebral artery dissection

Psychotic symptom

Urinary tract obstruction

Lung infiltration

Pleural effusion

Pneumonia aspiration

Orthostatic hypotension

Cardiac failure

Erysipelas

Shunt infection

Tonsillitis bacterial

Hip fracture

Traumatic intracranial haemorrhage

Wrist fracture

Cerebral infarction

Encephalopathy

Generalised tonic-clonic seizure

Hemiplegia

Neck pain

Pneumonia

Neurotoxicity

Syncope

Deep vein thrombosis

Giant cell arteritis

COVID-19

Ileus

Inguinal hernia

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Placebo

Part 1: Gantenerumab

Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg

Part 2 (OLE Treatment): Gantenerumab up to 1200 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: SCarlet RoADExperimental Treatment1 Intervention

Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.

Group II: Marguerite RoADExperimental Treatment1 Intervention

Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gantenerumab

2012

Completed Phase 3

~1590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,089,952 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,824 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many different places in the city where this trial is taking place?

"To make things as convenient as possible for those who choose to participate in this trial, 17 enrolment sites have been set up. These locations are situated in Sun City, Tampa, Matthews and other cities. When deciding whether or not to take part in the study, please consider how close the nearest site is to you."

Answered by AI

Gantenerumab: Is this medication risky for patients?

"This clinical trial is classified as a Phase 3, which means that there is some data supporting its efficacy and multiple rounds of data supporting its safety. Our team at Power estimates the safety of Gantenerumab to be a 3 on this scale."

Answered by AI

Have there been other similar trials before this one?

"At the moment, there are 5 ongoing clinical trials for Gantenerumab in 167 different cities and 33 countries. The first trial was held in 2018 and completed Phase 3 drug approval in that same year. Since then, 10 more studies have been completed."

Answered by AI

What does the literature say about Gantenerumab's efficacy?

"There are several clinical trials currently underway for Gantenerumab, with 4 in Phase 3. These studies are being conducted across 824 locations, including Donostia-san Sebastian and Guipuzcoa."

Answered by AI

Are investigators recruiting participants for this study at this time?

"Presently, this particular clinical trial is not looking for patients. Although, it's worth noting that the posting date was 5/22/2020 and the most recent update occurred on 9/23/2022. Alzheimer disease has 561 trials actively recruiting participants and Gantenerumab has 5 active trials enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04339413.