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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, 24, 41, 52, 76, 103, 115, 128, 164 and at early termination and unscheduled visit, week 1 and week 24 (open label extension)
Awards & highlights

Study Summary

This trial will compare the effects of gantenerumab (a drug) versus placebo (a fake drug) in people with early Alzheimer's disease. The study will last 116 weeks, and then participants will have the choice to continue receiving gantenerumab in an open-label extension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, 24, 41, 52, 76, 103, 115, 128, 164 and at early termination and unscheduled visit, week 1 and week 24 (open label extension)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, 24, 41, 52, 76, 103, 115, 128, 164 and at early termination and unscheduled visit, week 1 and week 24 (open label extension) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
China Extension: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
Secondary outcome measures
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog11 Score
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog13 Score
China - DBT Period: Change From Baseline to Week 116 in ADCS-ADL Total Score
+33 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
Placebo Group
Group I: GantenerumabExperimental Treatment1 Intervention
Gantenerumab will be administered as SC injections with gradual uptitration.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as SC injections with gradual uptitration.
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
2,428 Previous Clinical Trials
1,088,001 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,449 Total Patients Enrolled

Frequently Asked Questions

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

Do you have any information about how to sign up for the clinical trial?

"Currently, this clinical trial is looking for eligible patients. The first posting was on 6/6/2018, with the most recent update being on 10/23/2022, which can be found on clinicaltrials.gov"

Answered by AI

Does the age limit for this clinical trial set by researchers include people over 79 years old?

"This particular clinical trial is only for patients aged 50 to 90. In contrast, there are 25 other trials available for minors and 557 different trials open to adults over the age of 65."

Answered by AI

Are there other similar trials that have been conducted previously?

"Gantenerumab has been under clinical study since 2018. Its first trial, sponsored by Hoffmann-La Roche completed in that year with a sample size of 1016 patients. After the initial findings were promising, Gantenerumab received Phase 3 drug approval and is currently being trialed in 5 separate studies involving 167 cities and 33 countries."

Answered by AI

How does Gantenerumab compare to other treatment options in terms of safety?

"Since this is a Phase 3 trial, there is more data backing both the safety and efficacy of Gantenerumab. Our team has given it a rating of 3."

Answered by AI

Are there any other investigational uses for Gantenerumab?

"Gantenerumab is currently being studied in 5 active clinical trials, 4 of which are Phase 3. Although the majority of research locations for Gantenerumab are in Donostia-san Sebastian, Guipuzcoa, there are 824 total research sites for this medication."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
2018. "Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03444870.
~154 spots leftby Apr 2025
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