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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 from baseline (ole day 1) to week 208
Awards & highlights

Study Summary

This trial is to study the safety and effectiveness of a long-term administration of a drug called gantenerumab in people with Alzheimer's Disease who completed a previous study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (ole day 1) to week 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (ole day 1) to week 208 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
+2 more
Secondary outcome measures
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
+6 more
Other outcome measures
Plasma Concentration of Gantenerumab Administered SC

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
9%
Back pain
9%
Agitation
9%
Urinary tract infection
9%
Dizziness
8%
Constipation
8%
Insomnia
8%
Contusion
7%
Arthralgia
7%
Anxiety
7%
Depression
7%
Hypertension
7%
Influenza
7%
Vomiting
6%
Diarrhoea
6%
Skin abrasion
6%
Rash
5%
Nausea
5%
Oedema peripheral
5%
Bronchitis
4%
Upper respiratory tract infection
4%
Pyrexia
2%
Arrhythmia
1%
Femur fracture
1%
Cardiac arrest
1%
Acute coronary syndrome
1%
Atrial fibrillation
1%
Bradycardia
1%
Cardiac failure acute
1%
Myocardial infarction
1%
Diverticulum intestinal haemorrhagic
1%
Dysphagia
1%
Gastrointestinal haemorrhage
1%
Pancreatitis
1%
Cyst
1%
Pain
1%
Cholelithiasis
1%
Liver disorder
1%
Anaphylactic shock
1%
Cellulitis
1%
Colonic abscess
1%
Gastroenteritis rotavirus
1%
Ankle fracture
1%
Femoral neck fracture
1%
Meniscus injury
1%
Multiple fractures
1%
Road traffic accident
1%
Spinal compression fracture
1%
Subdural haematoma
1%
Upper limb fracture
1%
Hypoglycaemia
1%
Hyponatraemia
1%
Bladder transitional cell carcinoma
1%
Invasive lobular breast carcinoma
1%
Brain stem infarction
1%
Cerebral venous sinus thrombosis
1%
Dementia Alzheimer's type
1%
Epilepsy
1%
Hydrocephalus
1%
Leukoencephalopathy
1%
Psychomotor hyperactivity
1%
Vertebral artery dissection
1%
Psychotic symptom
1%
Urinary tract obstruction
1%
Lung infiltration
1%
Pleural effusion
1%
Pneumonia aspiration
1%
Orthostatic hypotension
1%
Cardiac failure
1%
Erysipelas
1%
Shunt infection
1%
Tonsillitis bacterial
1%
Hip fracture
1%
Traumatic intracranial haemorrhage
1%
Wrist fracture
1%
Cerebral infarction
1%
Encephalopathy
1%
Generalised tonic-clonic seizure
1%
Hemiplegia
1%
Neck pain
1%
Pneumonia
1%
Neurotoxicity
1%
Syncope
1%
Deep vein thrombosis
1%
Giant cell arteritis
1%
COVID-19
1%
Ileus
1%
Inguinal hernia
100%
80%
60%
40%
20%
0%
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: Group 2Experimental Treatment1 Intervention
Participants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE.
Group II: Group 1Experimental Treatment1 Intervention
Participants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gantenerumab
2012
Completed Phase 3
~1590

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,088,031 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,353 Total Patients Enrolled

Frequently Asked Questions

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

Does Gantenerumab have a extensive research history?

"Gantenerumab was first investigated in 2018 by researchers at Shanghai Mental health Center. So far, 10 studies have been completed while 5 more are ongoing. The recruiting trials are located primarily in Houston, Texas."

Answered by AI

Are we still enrolling participants for this research project?

"Yes, this study is still looking for participants according to the information on clinicaltrials.gov. The listing was first posted on February 1st, 2021 and was last edited on October 23rd, 2022."

Answered by AI

Is Gantenerumab likely to cause any harm to patients?

"There is both evidence of efficacy and safety for Gantenerumab, so it received a score of 3."

Answered by AI

Is this trial being conducted in more than one place within the city limits?

"This clinical trial has 49 locations where it is taking place, these locations include The University of Texas Health Science Center at Houston in Houston, Abington Neurological Associates in Abington, and UNiversity of Rochester in Rochester, as well as other locations."

Answered by AI

Does this trial's design differ from other trials in any way?

"As of now, there are 5 on-going trials for Gantenerumab in 167 cities and 33 nations. The earliest study related to this medication was in 2018 and was completed in the Phase 3 drug approval stage. This trial, which was sponsored by Hoffmann-La Roche, had a sample size of 1016 patients. In the 2 years since 2018, 10 more trials have been done."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Georgia
How old are they?
65+
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Hoping to slow progression of this disease.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
2021. "A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04374253.
~331 spots leftby Apr 2025
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