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Monoclonal Antibodies

Part 1: Gantenerumab for Alzheimer's Disease (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 part 2 week 208
Awards & highlights

DIAN-TU Trial Summary

This trial will study if treatment with an investigational study drug can prevent or slow the rate of Alzheimer's disease (AD)-causing accumulation of amyloid beta (Aβ). Part 1 will use Aβ positron emission tomography (PET) imaging to determine if treatment with the study drug prevents or slows the rate of Aβ pathological disease accumulation. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD.

Eligible Conditions
  • Familial Alzheimer Disease
  • Dementia
  • Alzheimer's Disease

DIAN-TU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 2 week 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 2 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
Part 1: Difference in change from baseline in amyloid deposition as measured by [11C]PiB-PET average cortical composite between active drug and placebo groups.
Part 2: Odds ratio between treated group and the external control group of being in the lower biomarker disease progression stage based on two-stage modeling of 6 biomarkers.

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

DIAN-TU Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part 1: GantenerumabExperimental Treatment1 Intervention
Active gantenerumab- blinded
Group II: Part 2: Gantenerumab Open LabelActive Control1 Intervention
Open label will start after last dose of Part 1
Group III: Part 1: Matching placebo (Gantenerumab)Placebo Group1 Intervention
Matching placebo
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
1,933 Previous Clinical Trials
2,299,505 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,430 Previous Clinical Trials
1,089,202 Total Patients Enrolled
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,543 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for participants in this clinical trial?

"Unfortunately, this particular clinical trial is not enrolling participants at the moment. Although, it was last updated on September 22nd, 2022 and 783 other trials are actively looking for candidates."

Answered by AI

Are there multiple testing sites for this new treatment?

"This trial has 16 enrolling sites, with locations including Dallas, Atlanta and Birmingham."

Answered by AI
Recent research and studies
Alzheimer's Research & TherapyJournal
A Survey of Attitudes Toward Clinical Trials and Genetic Disclosure in Autosomal Dominant Alzheimer’s Disease
Grill, Joshua D., Randall J. Bateman, Virginia Buckles, Angela Oliver, John C. Morris, Colin L. Masters, William E. Klunk, John M. Ringman, and for the Dominantly Inherited Alzheimer’s Network. 2015. “A Survey of Attitudes Toward Clinical Trials and Genetic Disclosure in Autosomal Dominant Alzheimer’s Disease”. Alzheimer's Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/s13195-015-0135-0.
NeurologyJournal
Longitudinal Cognitive and Biomarker Changes in Dominantly Inherited Alzheimer Disease
McDade, Eric, Guoqiao Wang, Brian A. Gordon, Jason Hassenstab, Tammie L.S. Benzinger, Virginia Buckles, Anne M. Fagan, et al.. 2018. “Longitudinal Cognitive and Biomarker Changes in Dominantly Inherited Alzheimer Disease”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000006277.
Alzheimer's & DementiaJournal
Collaboration for Alzheimer's Prevention: Principles to Guide Data and Sample Sharing in Preclinical Alzheimer's Disease Trials
Weninger, Stacie, Maria C. Carrillo, Billy Dunn, Paul S. Aisen, Randall J. Bateman, Joanne D. Kotz, Jessica B. Langbaum, et al.. 2016. “Collaboration for Alzheimer's Prevention: Principles to Guide Data and Sample Sharing in Preclinical Alzheimer's Disease Trials”. Alzheimer's & Dementia. Wiley. doi:10.1016/j.jalz.2016.04.001.
NatureJournal
Stop Alzheimer’s Before It Starts
McDade, Eric, and Randall J. Bateman. 2017. “Stop Alzheimer’s Before It Starts”. Nature. Springer Science and Business Media LLC. doi:10.1038/547153a.
~147 spots leftby Nov 2029
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