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Monoclonal Antibodies

Gantenerumab for Alzheimer's Disease (SKYLINE Trial)

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 up to week 211
Awards & highlights

SKYLINE Trial Summary

This trial will study whether gantenerumab is effective and safe in people with early Alzheimer's disease.

Eligible Conditions
  • Alzheimer's Disease

SKYLINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 211
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 211 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 to Year 4 in Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) Score
Secondary outcome measures
Change from Baseline to Year 4 in the Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV)
Change from Baseline to Year 4 in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Change from Baseline to Year 4 in the Cognitive Function Instrument Acute (CFIa)
+18 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

SKYLINE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GantenerumabExperimental Treatment1 Intervention
Gantenerumab will be administered as subcutaneous (SC) injection with gradual uptitration.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as SC injection 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
2,430 Previous Clinical Trials
1,089,386 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,708 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial available to middle-aged adults?

"This particular clinical trial only accepts patients that are between 60 and 80 years old. Out of the 576 total trials, 23 cater to a younger demographic while 553 focus on older individuals."

Answered by AI

What are the negative side effects of Gantenerumab?

"There is some evidence, from both this Phase 3 trial and other trials, that suggests Gantenerumab is safe for use."

Answered by AI

How many individual hospitals or other medical facilities are participating in this clinical trial?

"There are 39 clinical trial sites available for this study, some of which include Ohio State University; College of Medicine in Columbus, Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute in Tampa, and Banner Alzheimer's Institute in Tucson."

Answered by AI

Who is most likely to see benefits from participating in this research?

"This study is looking for 1200 participants aged 60-80 who have a diagnosis of Alzheimer's disease. In addition to this, the following criteria must be met: evidence of cerebral amyloid accumulation, a willing and available study partner, adequate visual and auditory acuity, agreement not to participate in other research studies during the trial period, contraceptive measures taken by women of childbearing potential that result in a failure rate <1% per year, compliance with all aspects of the study protocol including cognitive and functional assessments, physical and neurological examinations, MRI, CSF collection, genotyping and PET imaging. Participants must also be fluent in"

Answered by AI

How many people have signed up to participate in this research project?

"Correct, the clinical trial is recruiting patients at this time. 39 locations are participating in the study, which was first posted on 4/19/2022 and last updated on 11/4/2022. The goal is to enroll 1200 individuals total."

Answered by AI

Are there any current vacancies for this experiment?

"Yes, this study is still looking for participants according to the clinicaltrials.gov website. The listing was first posted on April 19th, 2022 and last edited on November 4th of the same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
2022. "A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256134.
~8 spots leftby Apr 2025
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