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Monoclonal Antibodies

Disease-Modifying Drugs for Alzheimer's Disease (DIAN-TU Trial)

Phase 2 & 3
Recruiting
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
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family
Must not have
History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 52, 104, 156, and 208

Summary

This trialassesses if a study drug could slow Alzheimer's progression or improve related biomarkers.

Who is the study for?
This trial is for individuals aged 18-80 with or at risk of early onset Alzheimer's due to a genetic mutation. They must be able to undergo brain scans and tests, have a reliable study partner, and use effective contraception if applicable. Exclusions include significant health issues like heart disease, metal implants incompatible with MRI, recent drug/alcohol dependence, certain cancer histories, and pregnancy.
What is being tested?
The trial is testing the safety and effectiveness of drugs Gantenerumab, Solanezumab, E2814, Lecanemab against placebos in slowing cognitive decline or improving biomarkers in Alzheimer's patients. Participants will receive either one of the drugs or a placebo while researchers track their cognitive health over time.
What are the potential side effects?
Potential side effects may include injection site reactions (like redness or pain), headaches, fatigue, allergic responses to the medication components which could range from mild to severe depending on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can see and hear well enough to complete tests.
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I have a family history of Alzheimer's with a known mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have significant heart, liver, kidney, infectious, immune, or hormonal diseases.
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I am not pregnant and do not plan to become pregnant during the trial.
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I am not on blood thinners, except for low-dose aspirin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 52, 104, 156, and 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 52, 104, 156, and 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by the change from baseline in the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE)

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%
Agitation
9%
Back pain
9%
Urinary tract infection
9%
Dizziness
8%
Constipation
8%
Insomnia
8%
Contusion
7%
Anxiety
7%
Arthralgia
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%
Upper limb fracture
1%
Hypoglycaemia
1%
Hyponatraemia
1%
Pancreatitis
1%
Ankle fracture
1%
Multiple fractures
1%
Pain
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%
Cyst
1%
Cholelithiasis
1%
Liver disorder
1%
Anaphylactic shock
1%
Cellulitis
1%
Colonic abscess
1%
Gastroenteritis rotavirus
1%
Femoral neck fracture
1%
Meniscus injury
1%
Road traffic accident
1%
Spinal compression fracture
1%
Subdural haematoma
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

8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: SolanezumabExperimental Treatment1 Intervention
This arm completed and is closed.
Group II: Matching placebo (E2814) plus lecanemabExperimental Treatment2 Interventions
Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.
Group III: GantenerumabExperimental Treatment1 Intervention
This arm completed and is closed.
Group IV: E2814 plus lecanemabExperimental Treatment2 Interventions
Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 will receive intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 will receive intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.
Group V: Cognitive Run-inActive Control1 Intervention
Group VI: Gantenerumab Open Label ExtensionActive Control1 Intervention
Subcutaneously every 4 weeks at escalating doses
Group VII: Matching Placebo (Solanezumab)Placebo Group1 Intervention
This arm completed and is closed.
Group VIII: Matching placebo (Gantenerumab)Placebo Group1 Intervention
This arm completed and is closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gantenerumab
2012
Completed Phase 3
~1590
E2814
2019
Completed Phase 2
~80
Lecanemab
2020
Completed Phase 3
~3530
Solanezumab
2014
Completed Phase 3
~1400

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,803 Previous Clinical Trials
28,194,021 Total Patients Enrolled
Avid RadiopharmaceuticalsIndustry Sponsor
65 Previous Clinical Trials
9,224 Total Patients Enrolled
Eisai Inc.Industry Sponsor
522 Previous Clinical Trials
160,145 Total Patients Enrolled
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
309,895 Total Patients Enrolled
Alzheimer's AssociationOTHER
99 Previous Clinical Trials
42,954 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,343,772 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,465,894 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,463 Previous Clinical Trials
1,102,674 Total Patients Enrolled
Accelerating Medicines Partnership (AMP)OTHER
2 Previous Clinical Trials
391 Total Patients Enrolled
Randall J Bateman, MDStudy DirectorWashington University School of Medicine
5 Previous Clinical Trials
587 Total Patients Enrolled

Media Library

E2814 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01760005 — Phase 2 & 3
Alzheimer's Disease Research Study Groups: Gantenerumab, Cognitive Run-in, Matching Placebo (Solanezumab), E2814 plus lecanemab, Matching placebo (E2814) plus lecanemab, Gantenerumab Open Label Extension, Matching placebo (Gantenerumab), Solanezumab
Alzheimer's Disease Clinical Trial 2023: E2814 Highlights & Side Effects. Trial Name: NCT01760005 — Phase 2 & 3
E2814 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01760005 — Phase 2 & 3
~104 spots leftby Apr 2028
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