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Gantenerumab Open Label Extension for Dementia (DIAN-TU Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Washington University School of Medicine
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 week 0 and weeks 48, 104, and 156
Awards & highlights

Summary

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Eligible Conditions
  • Dementia
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 and weeks 48, 104, and 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and weeks 48, 104, and 156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in amyloid load as measured by [11C]PiB-PET composite standardized uptake value ration (C-SUVR)
Secondary study objectives
Annual Rate of change in Cerebrospinal Fluid (CSF) Amyloid Beta1-42/40
Annual Rate of change in Cerebrospinal Fluid (CSF) phosphorylated Tau (pTau)-181
Annual Rate of change in Clinical Dementia Rating (CDR) Global
+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%
Cardiac arrest
1%
Femur fracture
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: Gantenerumab Open Label ExtensionExperimental Treatment1 Intervention
Gantenerumab: Subcutaneously every 4 weeks, at escalating doses
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?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,550 Total Patients Enrolled
19 Trials studying Dementia
8,414 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,930 Total Patients Enrolled
281 Trials studying Dementia
23,628,948 Patients Enrolled for Dementia
Hoffmann-La RocheIndustry Sponsor
2,444 Previous Clinical Trials
1,093,049 Total Patients Enrolled
5 Trials studying Dementia
1,109 Patients Enrolled for Dementia
~14 spots leftby Sep 2025
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