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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 (DIAN-TU)

Primary Purpose

Alzheimers Disease, Dementia, Alzheimers Disease, Familial

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gantenerumab
Solanezumab
Matching Placebo (Gantenerumab)
Matching Placebo (Solanezumab)
Gantenerumab
E2814
Lecanemab
Matching Placebo (E2814)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimers Disease focused on measuring Alzheimer's, Alzheimer's Disease, Dementia, Mutation, Genetic Mutation, Dominantly Inherited Alzheimer's Disease, Dominantly Inherited Alzheimer Network, Autosomal Dominant Alzheimer's Disease, Early Onset Alzheimer's Disease, DIAN, DIAN-TU, DIAN TU, DIAD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama in BirminghamRecruiting
  • University of California San Diego Medical CenterRecruiting
  • USC Keck School of MedicineRecruiting
  • Yale University School of MedicineRecruiting
  • Emory UniversityRecruiting
  • Advocate Lutheran General HospitalRecruiting
  • Indiana University School of MedicineRecruiting
  • Washington University in St. LouisRecruiting
  • University of PittsburghRecruiting
  • Butler HospitalRecruiting
  • Kerwin Medical CenterRecruiting
  • University of WashingtonRecruiting
  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENIRecruiting
  • Neuroscience Research AustraliaRecruiting
  • Mental Health Research InstituteRecruiting
  • The McCuster Foundation of Alzheimer's Disease Research
  • Hospital das Clínicas da Faculdade de Medicina da USP
  • UBC HospitalRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • McGill Center for Studies in AgingRecruiting
  • CHU de Quebec - Hôpital de l' Enfant JésusRecruiting
  • Grupo de Neurociencias Sede de la Universidad de AntioquiaRecruiting
  • CHU de Toulouse - Hôpital PurpanRecruiting
  • Hopital Roger Salengro - CHU LilleRecruiting
  • Groupe Hospitalier Pitie-SalpetriereRecruiting
  • Hopital Neurologique Pierre WertheimerRecruiting
  • CHU de Rouen - Hôpital Charles NicolleRecruiting
  • Universitaetsklinikum Tubingen
  • LMU-Campus Grosshadern
  • St Vincent's University HospitalRecruiting
  • IRCCS Centro San Giovanni di Dio FatebenefratelliRecruiting
  • Azienda Ospedaliera Universitaria CareggiRecruiting
  • University of Tokyo Hospital
  • Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
  • Brain Research CenterRecruiting
  • University of Puerto Rico, School of MedicineRecruiting
  • Hospital Clínic I Provincial de BarcelonaRecruiting
  • The National Hospital for Neurology and NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

No Intervention

Active Comparator

Experimental

Experimental

Arm Label

Gantenerumab

Solanezumab

Matching placebo (Gantenerumab)

Matching Placebo (Solanezumab)

Cognitive Run-in

Gantenerumab Open Label Extension

E2814 plus lecanemab

Matching placebo (E2814) plus lecanemab

Arm Description

This arm completed and is closed.

This arm completed and is closed.

This arm completed and is closed.

This arm completed and is closed.

Subcutaneously every 4 weeks at escalating doses

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.

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.

Outcomes

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)
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)

Secondary Outcome Measures

Full Information

First Posted
December 26, 2012
Last Updated
October 6, 2023
Sponsor
Washington University School of Medicine
Collaborators
Eli Lilly and Company, Hoffmann-La Roche, Alzheimer's Association, National Institute on Aging (NIA), Avid Radiopharmaceuticals, Accelerating Medicines Partnership (AMP), Eisai Inc., Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT01760005
Brief Title
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
Acronym
DIAN-TU
Official Title
A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2012 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Eli Lilly and Company, Hoffmann-La Roche, Alzheimer's Association, National Institute on Aging (NIA), Avid Radiopharmaceuticals, Accelerating Medicines Partnership (AMP), Eisai Inc., Janssen, LP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This study will recruit participants from the Dominantly Inherited Alzheimer Network (DIAN) observational study, a multicenter international study supported by the National Institutes of Health (Grant Number U01-AG032438; RJ Bateman), Dominantly Inherited Alzheimer Network Trial Units (DIAN-TU) sites, DIAN-TU partner sites, DIAN Expanded Registry (DIAN-EXR), and families identified by the sites. As part of the DIAN-TU-001 protocol, participants undergo longitudinal assessments that include clinical assessment, cognitive testing, magnetic resonance imaging (MRI) and amyloid and tau positron emission tomography (PET) imaging, and analysis of blood and cerebrospinal fluid (CSF). Participants in DIAN are recruited from families that have at least one member who has been identified as having a mutation linked to dominantly inherited Alzheimer's disease (DIAD). The mutations in presenilin 1 (PSEN1), presenilin 2 (PSEN2) and amyloid precursor protein (APP) that are associated with dominantly inherited Alzheimer's disease have very high penetrance (near 100%). This study enrolls individuals who are either known to have a disease-causing mutation or who are at risk for such a mutation (the descendant or sibling of a proband with a known mutation) and unaware of their genetic status. Because the age at onset of cognitive changes is relatively consistent within each family and with each mutation, an age at onset is determined for each affected parent or mutation as part of the DIAN Observational (DIAN-OBS) study protocol. This study will enroll participants who are either asymptomatic and are within a specific window of time of expected age at onset for their family and/or mutation or who have symptoms of mild Alzheimer's disease. The ability to identify individuals destined to develop Alzheimer's disease (AD) and predict the age of onset with a high degree of confidence provides a unique opportunity to assess the efficacy of therapies at asymptomatic and very early stages of dementia. Families with known disease-causing mutations are extremely rare and are geographically dispersed throughout the world. These constraints necessitate a specialized study design. Many of the participants in this study will not yet have any cognitive symptoms of AD; they will be "asymptomatic" carriers of mutations that cause dominantly inherited Alzheimer's disease and would be expected to perform normally on standard cognitive and functional testing. Imaging and fluid biomarkers will be used to demonstrate that the treatment compounds have engaged their therapeutic targets. A set of cognitive measures designed to assess the very earliest and most subtle cognitive changes will be collected. Additionally, because many at-risk individuals decide not to know whether they have the disease-associated mutation or not, when allowable in individual drug arms, some of the at-risk individuals enrolled in this study will not have the disease-causing mutations; they will be "mutation negative". It is important to enroll these participants to avoid coercion (e.g., potential participants may be pressured into genetic testing to learn their genetic status in order to be eligible for the trial) unless the drug-specific design includes open-label treatment. These mutation negative individuals will be assigned to the placebo group and data will be used to determine normal ranges of outcome measures. Participants and site study staff will remain blinded as to these individuals' active or placebo group assignment and mutation status. Thus, the study will be double-blinded for placebo and for mutation status, except for mutation positive participants who are aware of their genetic status. There may be exceptional circumstances when required by local regulation or health authorities where enrollment may be restricted to mutation carriers only, but such mandates will be thoroughly documented and agreed upon by the governing regulatory agency and sponsor. This is an adaptive platform-based study. Several different therapies (each referred to as a study drug arm) will be tested in order to increase the likelihood that an effective treatment will be discovered. The compounds are selected for this trial based on mechanism of action and available data on efficacy and safety profile. The study design includes a pooled placebo group (referred to as the mutation positive placebos) which may be shared by study drug arms. Mutation positive participants will be assigned to a study drug arm and subsequently randomized within that arm to the active drug to placebo ratio specified in each drug-specific appendix. When included in individual drug arms, mutation negative participants will all receive placebo treatment. Participants and study staff will not be blinded as to which study drug arm each participant has been assigned; they will be blinded as to whether participants have been randomized to active drug or placebo. Biomarker, cognitive, and/or clinical endpoints will be specified for each study drug arm. Biomarker data will be analyzed for pre-specified endpoints consistent with the drug's mechanism of action and other AD biomarker outcomes. Interim analyses of the imaging or fluid biomarker endpoint will assess safety and whether each study drug engages its biological targets. The clinical and cognitive assessments are designed to assess subtle cognitive changes that may be detectable before the onset of dementia as well as cognitive and clinical decline in symptomatic groups. After the last participant in a study drug arm completes the 4-year treatment period, participants in that study drug arm may be eligible to receive active study drug in an open-label extension period. A cognitive run-in (CRI) period was implemented to allow for enrollment during periods when study drug arms are not randomizing. This enables the DIAN-TU platform to have continuous enrollment during periods before or in-between drug arm randomization. The CRI period of cognitive, clinical, and imaging data collection was designed as part of the platform study to utilize the time in between enrollment of study drug arms. The CRI period will enhance study enrollment by identifying eligible participants and engaging them with the cognitive assessments and can reduce practice effects by allowing participants to habituate to the testing process. The CRI further provides important baseline and run-in data that adds control data to the platform and informs about the effects of tested drugs. The data collected in the CRI period will be used for analysis in the respective drug arm under which participants are randomized and treated. Solanezumab and gantenerumab double blind treatment arms: Primary Completion Date= Nov 2019 and Study Completion= March 2020 (NCT04623242) Gantenerumab open-label extension is enrolling by invitation under this master protocol. Primary Completion Date= Sept 2024 E2814 treatment arm is enrolling: Primary Completion Date= July 2027 and Study Completion= Oct 2027 (NCT05269394)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimers Disease, Dementia, Alzheimers Disease, Familial
Keywords
Alzheimer's, Alzheimer's Disease, Dementia, Mutation, Genetic Mutation, Dominantly Inherited Alzheimer's Disease, Dominantly Inherited Alzheimer Network, Autosomal Dominant Alzheimer's Disease, Early Onset Alzheimer's Disease, DIAN, DIAN-TU, DIAN TU, DIAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Interventional with a non-interventional run-in component (Future interventions to be added)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
One arm is Open-label as noted in the arm descriptions
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gantenerumab
Arm Type
Experimental
Arm Description
This arm completed and is closed.
Arm Title
Solanezumab
Arm Type
Experimental
Arm Description
This arm completed and is closed.
Arm Title
Matching placebo (Gantenerumab)
Arm Type
Placebo Comparator
Arm Description
This arm completed and is closed.
Arm Title
Matching Placebo (Solanezumab)
Arm Type
Placebo Comparator
Arm Description
This arm completed and is closed.
Arm Title
Cognitive Run-in
Arm Type
No Intervention
Arm Title
Gantenerumab Open Label Extension
Arm Type
Active Comparator
Arm Description
Subcutaneously every 4 weeks at escalating doses
Arm Title
E2814 plus lecanemab
Arm Type
Experimental
Arm Description
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.
Arm Title
Matching placebo (E2814) plus lecanemab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Other Intervention Name(s)
RO4909832
Intervention Description
Subcutaneously every 4 weeks at escalating doses
Intervention Type
Drug
Intervention Name(s)
Solanezumab
Other Intervention Name(s)
LY2062430
Intervention Description
Intravenous infusion every 4 weeks at escalating doses
Intervention Type
Drug
Intervention Name(s)
Matching Placebo (Gantenerumab)
Intervention Description
Subcutaneous injection of placebo every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Matching Placebo (Solanezumab)
Intervention Description
Intravenous infusion of placebo every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Other Intervention Name(s)
RO4909832
Intervention Description
Open-label administered Subcutaneously every 4 weeks at escalating doses
Intervention Type
Drug
Intervention Name(s)
E2814
Intervention Description
Administered intravenously in a blinded fashion
Intervention Type
Drug
Intervention Name(s)
Lecanemab
Other Intervention Name(s)
BAN2401
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Matching Placebo (E2814)
Intervention Description
Placebo administered intravenously in a blinded fashion.
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
Baseline and Weeks 52, 104, 156, and 208

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Ziegemeier, MA
Phone
844-DIANEXR (342-6397)
Email
dianexr@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Bartzel
Phone
844-DIANEXR (342-6397)
Email
dianexr@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall J Bateman, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama in Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Roberson
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Galasko
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Pawluczyk
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Van Dyck
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lah
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Gitelman
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Brosch
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Snider
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Berman
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Surti
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Kerwin
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suman Jayadev
Facility Name
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1428AQK
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Allegri
Facility Name
Neuroscience Research Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Brooks
Facility Name
Mental Health Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Masters
Facility Name
The McCuster Foundation of Alzheimer's Disease Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonel Takada
Facility Name
UBC Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Hsiung
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Masellis
Facility Name
McGill Center for Studies in Aging
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Rosa-Neto
Facility Name
CHU de Quebec - Hôpital de l' Enfant Jésus
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert LaForce
Facility Name
Grupo de Neurociencias Sede de la Universidad de Antioquia
City
Medellín
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Lopera, M.D.
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Pariente
Facility Name
Hopital Roger Salengro - CHU Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Pasquier
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris cedex 13
State/Province
Paris
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Levy
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Bron cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maité Formaglio
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wallon
Facility Name
Universitaetsklinikum Tubingen
City
Tübingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristoph Laske, M.D.
Facility Name
LMU-Campus Grosshadern
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Levin, M.D,
Facility Name
St Vincent's University Hospital
City
Dublin
ZIP/Postal Code
DUBLIN 4
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Kinsella
Facility Name
IRCCS Centro San Giovanni di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Frisoni, M.D,
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Sorbi, M.D.
Facility Name
University of Tokyo Hospital
City
Bunkyō-Ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryoko Ihara, M.D.
Facility Name
Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Luisa Sosa Ortiz, M.D.
Facility Name
Brain Research Center
City
Amsterdam
ZIP/Postal Code
1081 GM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jort Vijverberg, MD
Facility Name
University of Puerto Rico, School of Medicine
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivonne Jimenez-Velazquez
Facility Name
Hospital Clínic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Sanchez Valle
Facility Name
The National Hospital for Neurology and Neurosurgery
City
London
State/Province
Greater London
ZIP/Postal Code
WC1B 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Mummery

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].
Citations:
PubMed Identifier
22784036
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
29761523
Citation
Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.
Results Reference
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PubMed Identifier
27157073
Citation
Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.
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Citation
McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.
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Results Reference
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Links:
URL
http://www.dianexr.org/
Description
Expanded registry

Learn more about this trial

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

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