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Clinical Trials in Germany / NCT01760005
Active, not recruiting Phase 2/3

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

NCT01760005 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2/3
Started
2012-12
Last updated
2026-07-27

Condition(s) studied

Alzheimers DiseaseDementiaAlzheimers Disease, Familial

Investigational drug(s) / intervention(s)

GantenerumabSolanezumabMatching Placebo (Gantenerumab)Matching Placebo (Solanezumab)GantenerumabE2814 →Lecanemab →Matching Placebo (E2814)

Gantenerumab: Subcutaneously every 4 weeks at escalating doses

Solanezumab: Intravenous infusion every 4 weeks at escalating doses

Matching Placebo (Gantenerumab): Subcutaneous injection of placebo every 4 weeks

Matching Placebo (Solanezumab): Intravenous infusion of placebo every 4 weeks

Gantenerumab: Open-label administered Subcutaneously every 4 weeks at escalating doses

E2814: Administered intravenously in a blinded fashion

Lecanemab: Administered intravenously

Matching Placebo (E2814): Placebo administered intravenously in a blinded fashion.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Between 18-80 years of age * 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. * Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected or actual age of cognitive symptom onset. * Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive) * Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning * Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations. * For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide). * Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. * Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion. Exclusion Criteria: * History or presence of brain MRI scans indicative of any other significant abnormality * Alcohol or drug dependence currently or within the past 1 year * Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan. * History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders * Anticoagulants except low dose (≤ 325 mg) aspirin. * Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months. * History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years. * Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial. * Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
University of Alabama in Birmingham Birmingham Alabama
University of California San Diego Medical Center La Jolla California
USC Keck School of Medicine Los Angeles California
Yale University School of Medicine New Haven Connecticut
Emory University Atlanta Georgia
Advocate Lutheran General Hospital Park Ridge Illinois
Indiana University School of Medicine Indianapolis Indiana
Washington University in St. Louis St Louis Missouri
University of Pittsburgh Pittsburgh Pennsylvania
Butler Hospital Providence Rhode Island
Kerwin Medical Center Dallas Texas
University of Washington Seattle Washington
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI Ciudad Autonoma de Buenos Aire Argentina
Neuroscience Research Australia Randwick New South Wales
Alzheimer's Research Australia Melbourne Victoria
The McCuster Foundation of Alzheimer's Disease Research Nedlands Western Australia
Hospital das Clínicas da Faculdade de Medicina da USP São Paulo Brazil
UBC Hospital Vancouver British Columbia
Sunnybrook Health Sciences Centre Toronto Ontario
McGill Center for Studies in Aging Verdun Quebec
CHU de Quebec - Hôpital de l' Enfant Jésus Québec Canada
Grupo de Neurociencias Sede de la Universidad de Antioquia Medellín Colombia
CHU de Toulouse - Hôpital Purpan Toulouse Haute Garonne
Hopital Roger Salengro - CHU Lille Lille Nord
Groupe Hospitalier Pitie-Salpetriere Paris Paris
Hopital Neurologique Pierre Wertheimer Bron Rhone
CHU de Rouen - Hôpital Charles Nicolle Rouen Seine Maritime
Universitaetsklinikum Tubingen Tübingen Baden-Wurttemberg
LMU-Campus Grosshadern Munich Bavaria
St Vincent's University Hospital Dublin Ireland
IRCCS Centro San Giovanni di Dio Fatebenefratelli Brescia Italy
Azienda Ospedaliera Universitaria Careggi Florence Italy
Niigata University Medical & Dental Hospital Niigata Niigata
University of Tokyo Hospital Bunkyō City Tokyo-To
Brain Research Center Amsterdam Netherlands
University of Puerto Rico, School of Medicine San Juan Puerto Rico
Hospital Clínic I Provincial de Barcelona Barcelona Spain
The National Hospital for Neurology and Neurosurgery London Greater London

On this site

📄 Leqembi (lecanemab) drug profile →

More Washington University School of Medicine trials in Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01760005 on ClinicalTrials.gov ↗ ← All trials in Germany