Trial record 1 of 6 for:    DIAN
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Dominantly Inherited Alzheimer Network (DIAN)

This study is currently recruiting participants.
Verified February 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00869817
First received: March 25, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dominantly Inherited Alzheimer Network (DIAN)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Positive predictive power of a biomarker or group of biomarkers [ Time Frame: Variable follow-up assessment based on age in relation to age at onset of affected parent. ] [ Designated as safety issue: No ]
  • Biomarkers obtained by blood draw, lumbar puncture, MRI, FDG PET, PET amyloid imaging [ Time Frame: Variable follow-up assessment based on age in relation to age at onset of affected parent ] [ Designated as safety issue: No ]
  • Clinical markers also examined from clinical interview and cognitive testing [ Time Frame: Variable follow-up assessment based on age in relation to age at onset of affected parent ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma, cerebral spinal fluid


Estimated Enrollment: 400
Study Start Date: January 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mutation Positive
2
Mutation Negative

Detailed Description:

Dominantly inherited Alzheimer's disease (AD) represents less than 1% of all cases of AD and is an important model for study because the responsible mutations have known biochemical consequences that are believed to underlie the pathological basis of the disorder. Three major hypotheses will be tested:

  • First, that there is a period of preclinical (presymptomatic) AD in individuals who are destined to develop early-onset dementia (gene carriers) that can be detected by changes in biological fluids and in neuroimaging correlates in comparison with individuals who will not develop early-onset dementia (non-carriers).
  • Second, because all identified causative mutations for AD affect the normal processing of amyloid precursor protein (APP) and increase brain levels of amyloid-beta 42 (Aβ42), the sequence of preclinical changes initially will involve Aβ42 (production and clearance; reduced levels in cerebrospinal fluid [CSF]), followed by evidence for cerebral deposition of Aβ42 (amyloid imaging), followed by cerebral metabolic activity (functional imaging), and finally by regional atrophy (structural imaging).
  • Finally, that the phenotype of symptomatic early-onset familial AD, including its clinical course, is similar to that of late-onset "sporadic" AD.

The following specific aims will be used to test these hypotheses:

  1. Establish an international, multicenter registry of individuals (mutation carriers and non-carriers; pre-symptomatic and symptomatic) who are biological adult children of a parent with a known causative mutation for AD in the APP, PSEN1, or PSEN2 genes in which the individuals are evaluated in a uniform manner at entry and longitudinally thereafter with standardized instruments.
  2. In pre-symptomatic individuals, compare mutation carriers and non-carriers to determine the order in which changes in clinical, cognitive, neuroimaging, and biomarker indicators of AD occur prior to the occurrence of dementia.
  3. In symptomatic individuals, compare the clinical and neuropathological phenotypes of autosomal dominant AD to those of late-onset "sporadic" AD (using the data sets established by ADNI and by NACC).
  4. Maintain the DIAN Central Archive, an integrated database incorporating all information obtained from individuals in the registry to permit analyses within, between, and among the various data domains and also to disseminate the data to qualified investigators in a user-friendly manner.
  5. All DIAN participants who wish to know their mutation status will have the costs of genetic counseling and clinical mutation testing paid for by the grant. The clinical genetic counseling and testing is provided as an optional participant benefit and is not part of the DIAN research design.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mutation carriers and non-carriers from families with a mutation (which is different from the genetic risk factor Apo-E4) known to cause Alzheimer's disease.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Child of an individual with a known mutation in a pedigree with autosomal dominant Alzheimer's disease
  • Cognitively normal, or if demented, does not require nursing home level care
  • Fluent in English or Spanish at the 6th grade level
  • Has someone who is not a child of the affected parent who can serve as an informant for the study

Exclusion Criteria:

  • Under age 18
  • Medical or psychiatric illness that would interfere in completing initial and follow-up visits
  • Requires nursing home level care
  • Has no one who can serve as a study informant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869817

Contacts
Contact: DIAN Global Coordinator 314-286-2683

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: David Wharton, BA    805-509-1842    dwharton@mednet.ucla.edu   
Principal Investigator: John Ringman, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Dana Haley, MPH CCRP    904-953-9680    Kistler.Dana@mayo.edu   
Principal Investigator: Neill R. Graff-Radford, MD         
United States, Indiana
Indiana University-Indiana Alzheimer Disease Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Francine Epperson, AGS    317-274-1590    freppers@iupui.edu   
Principal Investigator: Bernardino Ghetti, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sehily Jaimes, BA    617-643-5200    sjaimes@partners.org   
Principal Investigator: Reisa Sperling, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63108
Contact: Wendy Sigurdson, RN, MPH    314-362-2256    sigurdsonw@neuro.wustl.edu   
Principal Investigator: Randall Bateman, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Amanda L. Sena, M.S., C.G.C.    212-305-5097    als2279@columbia.edu   
Principal Investigator: Richard Mayeux, MD, MSc         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Eric McDade, DO    412-692-2732    mcdadee@upmc.edu   
Principal Investigator: Eric McDade, DO         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Erin Poyant    401-455-6403    epoyant@butler.org   
Principal Investigator: Stephen Salloway, MD         
Australia, New South Wales
Neuroscience Research Australia Recruiting
Sydney, New South Wales, Australia, 2031
Contact: William S. Brooks, MBBS, MPH    +612 9399 1101    w.brooks@NeuRA.edu.au   
Principal Investigator: Peter Schofield, PhD, DSc         
Australia, Victoria
Mental Health Research Institute, University of Melbourne Recruiting
Melbourne, Victoria, Australia, 3130
Contact: Lesley Vidaurre, RN    +61 3 8344 1859    lesley.vidaurre@florey.edu.au   
Principal Investigator: Colin Masters, MD         
Australia, Western Australia
Sir James McCusker Alzheimer's Disease Research Unit, Edith Cowan University Recruiting
Perth, Western Australia, Australia, 6009
Contact: Kevin Taddei    +61-(0)8-6304-5107    k.taddei@ecu.edu.au   
Principal Investigator: Ralph Martins, PhD         
Germany
German Center for Neurodegenerative Diseases (DZNE) Munich, and University Hospital Ludwig-Maximilians-Universitat (LMU) Munich Recruiting
Munich, Germany, D-81377
Contact: Theresa Raiser    +49 89 7095-4828    theresa.raiser@med.uni-muenchen.de   
Principal Investigator: Adrian Danek, MD         
German Center for Neurodegenerative Diseases (DZNE) Tübingen and Hertie-Institute for Clinical Brain Research, University of Tübingen Recruiting
Tübingen, Germany, D-72076
Contact: Elke Kuder-Buletta    +49-(0)7071-2987584    Elke.Buletta@med.uni-tuebingen.de   
Principal Investigator: Mathias Jucker, PhD         
United Kingdom
Institute of Neurology, Queen Square Recruiting
London, United Kingdom, WC1N 3BG
Contact: Jane Douglas, RN MPhil.    0044 (0)845 155 5000 ext 723560    jdouglas@drc.ion.ac.uk   
Principal Investigator: Martin Rossor, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John C. Morris, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00869817     History of Changes
Other Study ID Numbers: IA0147, U19AG032438
Study First Received: March 25, 2009
Last Updated: February 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Alzheimer's disease
antecedent biomarkers
Amyloid Precursor Protein (APP) mutation
presenilin I (PS1) mutation
presenilin 2 (PS2) mutation
Autosomal Dominant Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014