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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- 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) — Baseline and Weeks 52, 104, 156, and 208
The DIAN-Multivariate Cognitive Endpoint (DIAN-MCE) consists of 4 cognitive measures: Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test, Wechsler Adult Intelligence Sale Digit Symbol Substitution Test (WAIS), International Shopping List Task (ISLT), Mini-Mental State Examination (MMSE)
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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Other trials for the same condition
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 Spain