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Monoclonal Antibodies

Gantenerumab for Alzheimer's Disease

Phase 2
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 day 4 of week 1, week 24, 36, 52, and 76
Awards & highlights

Study Summary

This trial will evaluate the effect of a once-weekly injection of the drug gantenerumab on amyloid deposits in the brains of patients with early Alzheimer's disease, compared to their condition at the beginning of the trial and at 104 and 208 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4 of week 1, week 24, 36, 52, and 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 of week 1, week 24, 36, 52, and 76 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 From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan
Secondary outcome measures
Change in Brain Amyloid Based on Different Dosing Frequency
Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+6 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
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

1Treatment groups
Experimental Treatment
Group I: GantenerumabExperimental Treatment1 Intervention
Participants will receive gantenerumab by subcutaneous (SC) injection at a dose of 120 mg every 4 weeks (Q4W) for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg every 2 weeks (Q2W) for another 12 weeks, followed by the target dose 255 mg once weekly (Q1W) for up to Week 103. Participants who complete Week 104 visit will be given an option to take part in 2-year extension of the study to receive gantenerumab 255 mg Q1W for up to Week 207.
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
1,088,873 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,253 Total Patients Enrolled

Frequently Asked Questions

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

Could you tell me the scope of this research project in terms of patient participation?

"This medical trial has now closed for further enrolment. The initial posting date was November 18th 2020 and the latest update occured on September 23rd 2022. For those in search of alternative trials, 546 studies related to Alzheimer's disease are still open and 6 clinical studies that use Gantenerumab as a treatment are actively recruiting patients."

Answered by AI

Are recruitment activities currently being conducted for this research project?

"Unfortunately, this research project is no longer taking on new recruits. Initially posted in November 2020 and last edited in September 2022, it has now filled its quota of participants. If you're looking for a clinical trial to join at present, there are 546 studies with Alzheimer’s as the primary focus and 6 additional trials that have Gantenerumab as their intervention."

Answered by AI

Is this particular clinical trial a pioneering exploration of its kind?

"At present, 188 cities and 34 different nations are hosting 6 separate trials for Gantenerumab. The first of these studies was conducted in 2012 by Eisai Inc., which sought to demonstrate the efficacy of this drug through a Phase 2 & 3 clinical trial involving 490 participants. In the years since then, 10 additional trials have been launched."

Answered by AI

What potential deleterious impacts could Gantenerumab pose to individuals?

"The safety profile of Gantenerumab was judged to have a risk rating of 2, as there is limited data regarding its efficacy but existing studies indicate it may be safe."

Answered by AI

Are there any other research projects involving Gantenerumab that have taken place in recent years?

"Currently, there are 6 ongoing studies of Gantenerumab in the third phase. With most trials located in Dallas, Texas, this medication's clinical trails span 866 sites across America."

Answered by AI

Does the research study permit enrollment of individuals over 65 years old?

"This clinical trial adheres to an age range of 50-90 for its inclusion criteria, meaning that participants must be between these two ages to qualify."

Answered by AI

How many places are carrying out this clinical assessment?

"The current clinical trial is active in 8 different locations, such as Ocala, Gainesville and Willow Grove. To minimize travel time it is recommended to pick the closest site to your residence when enrolling."

Answered by AI

Who is eligible to participate in this clinical investigation?

"This particular medical trial is recruiting 192 participants, with an age range of 50 to 90 years old and a diagnosis of Alzheimer's disease. To be eligible for the study, they must also have adequate auditory/visual acuity to perform neuropsychological testing (with aids if necessary), confirmation of AD pathological process via amyloid PET scan, prodromal or mild symptomatology as determined by MMSE and CDR-GS scores, stable dosing regimen on symptomatic medications for 3 months prior to screening and until start of treatment period. Additionally, female participants must agree not to donate blood or participate in other research studies during this trial"

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Alzheimer's Research and Treatment Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~43 spots leftby Apr 2025