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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

DIAN-TU Trial 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.Check my eligibility

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.See study design

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.

DIAN-TU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can see and hear well enough to complete tests.

Select...

I have a family history of Alzheimer's with a known mutation.

DIAN-TU Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Back pain

Agitation

Urinary tract infection

Dizziness

Constipation

Insomnia

Contusion

Arthralgia

Anxiety

Depression

Hypertension

Influenza

Vomiting

Diarrhoea

Skin abrasion

Rash

Nausea

Oedema peripheral

Bronchitis

Upper respiratory tract infection

Pyrexia

Arrhythmia

Femur fracture

Cardiac arrest

Acute coronary syndrome

Atrial fibrillation

Bradycardia

Cardiac failure acute

Myocardial infarction

Diverticulum intestinal haemorrhagic

Dysphagia

Gastrointestinal haemorrhage

Pancreatitis

Cyst

Pain

Cholelithiasis

Liver disorder

Anaphylactic shock

Cellulitis

Colonic abscess

Gastroenteritis rotavirus

Ankle fracture

Femoral neck fracture

Meniscus injury

Multiple fractures

Road traffic accident

Spinal compression fracture

Subdural haematoma

Upper limb fracture

Hypoglycaemia

Hyponatraemia

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

DIAN-TU 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 1

~80

Lecanemab

2022

Completed Phase 1

~220

Solanezumab

2014

Completed Phase 3

~1400

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,573 Total Patients Enrolled

Avid RadiopharmaceuticalsIndustry Sponsor

65 Previous Clinical Trials

9,224 Total Patients Enrolled

Eisai Inc.Industry Sponsor

515 Previous Clinical Trials

153,492 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

Frequently Asked Questions

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

What other research endeavors have been undertaken to explore the use of Gantenerumab?

"At present, Gantenerumab is the subject of 7 active clinical trials with 6 in their third phase. While certain studies are being conducted at locations in Dallas, Texas, a total of 933 sites have been utilized for its investigation."

Answered by AI

Does this clinical research encompass participants aged 25 and above?

"This research endeavour is searching for subjects aged 18 or older, but younger than the octogenarian age of 80."

Answered by AI

Are there multiple healthcare facilities running the research trial in city?

"The University of Alabama in Birmingham, USC Keck School of Medicine, and Indiana University School of Medicine are the leading institutions running this clinical trial. Additionally, 16 more sites across America are involved with the research."

Answered by AI

What is the aggregate of participants involved in this medical trial?

"Affirmative. Referring to the information accessible on clinicaltrials.gov, this investigation is in its recruitment phase, commencing December 1st 2012 and last updated November 27th 2022. The trial requires a total of 490 participants from 16 different medical centres."

Answered by AI

Is enrollment currently open for this medical trial?

"Affirmative. From the information on clinicaltrials.gov, it is clear that this medical study has been seeking patients since December 1st 2012 and was recently updated by November 27th 2022. It requires 490 participants to be recruited from 16 different medical centres across the country."

Answered by AI

Could I potentially qualify to partake in this research endeavor?

"This clinical trial seeks 490 individuals aged 18 to 80 years old who have been diagnosed with dementia. Prospective participants must also possess the visual and auditory capabilities needed for cognitive and functional assessments, be accompanied by a Study Partner willing to provide accurate information about their abilities, either know they possess an Alzheimer's disease-causing mutation or are unaware of their genetic status but do come from a family where dominantly inherited Alzheimer's Disease is present; additionally, age should lie between 15 years prior to expected symptom onset up until 10 after it has occurred (or actual symptom onset if applicable). Those being assessed must also exhibit mild cognitive impairment or dementia according to"

Answered by AI

Has something similar been done before in regards to this research?

"As of now, 7 research studies related to Gantenerumab are underway across 205 cities and 34 countries. The initial clinical trial for the drug began in 2012 under Eisai Inc., recruiting a total of 490 participants and going through both Phase 2 & 3 trials before completion. Since then, 16 more studies have been completed."

Answered by AI