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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and weeks 52, 104, 156, and 208

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

Agitation

Back pain

Urinary tract infection

Dizziness

Constipation

Insomnia

Contusion

Anxiety

Arthralgia

Depression

Hypertension

Influenza

Vomiting

Diarrhoea

Skin abrasion

Rash

Nausea

Oedema peripheral

Bronchitis

Upper respiratory tract infection

Pyrexia

Arrhythmia

Multiple fractures

Hypoglycaemia

Hyponatraemia

Pancreatitis

Upper limb fracture

Ankle fracture

Pain

Cardiac arrest

Femur fracture

Acute coronary syndrome

Atrial fibrillation

Bradycardia

Cardiac failure acute

Myocardial infarction

Diverticulum intestinal haemorrhagic

Dysphagia

Gastrointestinal haemorrhage

Cyst

Cholelithiasis

Liver disorder

Anaphylactic shock

Cellulitis

Colonic abscess

Gastroenteritis rotavirus

Femoral neck fracture

Meniscus injury

Road traffic accident

Spinal compression fracture

Subdural haematoma

Bladder transitional cell carcinoma

Invasive lobular breast carcinoma

Brain stem infarction

Cerebral venous sinus thrombosis

Dementia Alzheimer's type

Epilepsy

Hydrocephalus

Leukoencephalopathy

Psychomotor hyperactivity

Vertebral artery dissection

Psychotic symptom

Urinary tract obstruction

Lung infiltration

Pleural effusion

Pneumonia aspiration

Orthostatic hypotension

Cardiac failure

Erysipelas

Shunt infection

Tonsillitis bacterial

Hip fracture

Traumatic intracranial haemorrhage

Wrist fracture

Cerebral infarction

Encephalopathy

Generalised tonic-clonic seizure

Hemiplegia

Neck pain

Pneumonia

Neurotoxicity

Syncope

Deep vein thrombosis

Giant cell arteritis

COVID-19

Ileus

Inguinal hernia

100%

80%

60%

40%

20%

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