Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00869817




Registration number
NCT00869817
Ethics application status
Date submitted
25/03/2009
Date registered
26/03/2009
Date last updated
25/04/2024

Titles & IDs
Public title
Dominantly Inherited Alzheimer Network (DIAN)
Scientific title
Dominantly Inherited Alzheimer Network (DIAN)
Secondary ID [1] 0 0
U19AG032438
Secondary ID [2] 0 0
IA0147
Universal Trial Number (UTN)
Trial acronym
DIAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Mutation Positive

2 - Mutation Negative
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive predictive power of a biomarker or group of biomarkers
Timepoint [1] 0 0
Variable follow-up assessment based on age in relation to age at onset of affected parent.
Primary outcome [2] 0 0
Biomarkers obtained by blood draw, lumbar puncture, MRI, FDG PET, PET amyloid imaging
Timepoint [2] 0 0
Variable follow-up assessment based on age in relation to age at onset of affected parent
Primary outcome [3] 0 0
Clinical markers also examined from clinical interview and cognitive testing
Timepoint [3] 0 0
Variable follow-up assessment based on age in relation to age at onset of affected parent

Eligibility
Key inclusion criteria
- Written informed consent obtained from participant and collateral source prior to any
study-related procedures.

- Aged 18 (inclusive) or older and the child of an affected individual (clinically or by
testing) in a pedigree with a known mutation for ADAD.

- Cognitively normal to very mild or mild cognitive impairment (CDR score range 0-1.0).
Primary enrollment will focus on the recruitment of asymptomatic adult children who
are more than 15 years younger than the estimated age of symptom onset. Enrollment of
new participants with moderate cognitive impairment is allowed with the prior approval
of the DIAN Coordinating Center.

- Has two persons who are not their full-blooded siblings who can serve as collateral
sources for the study.

- Fluent in a language approved by the DIAN Coordinating Center at about the 6th grade
level (international equivalent) or above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Sydney
Recruitment hospital [2] 0 0
Mental Health Research Institute, University of Melbourne - Melbourne
Recruitment hospital [3] 0 0
Sir James McCusker Alzheimer's Disease Research Unit, Edith Cowan University - Perth
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
3130 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Salta
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Colombia
State/province [12] 0 0
Medellín
Country [13] 0 0
Germany
State/province [13] 0 0
Munich
Country [14] 0 0
Germany
State/province [14] 0 0
Tübingen
Country [15] 0 0
Japan
State/province [15] 0 0
Niigata
Country [16] 0 0
Japan
State/province [16] 0 0
Osaka City
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Songpa-Gu
Country [19] 0 0
Mexico
State/province [19] 0 0
Mexico City
Country [20] 0 0
Spain
State/province [20] 0 0
Catalunya
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Washington University School of Medicine
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00869817
Trial related presentations / publications
Mintun MA, Larossa GN, Sheline YI, Dence CS, Lee SY, Mach RH, Klunk WE, Mathis CA, DeKosky ST, Morris JC. [11C]PIB in a nondemented population: potential antecedent marker of Alzheimer disease. Neurology. 2006 Aug 8;67(3):446-52. doi: 10.1212/01.wnl.0000228230.26044.a4.
Fagan AM, Roe CM, Xiong C, Mintun MA, Morris JC, Holtzman DM. Cerebrospinal fluid tau/beta-amyloid(42) ratio as a prediction of cognitive decline in nondemented older adults. Arch Neurol. 2007 Mar;64(3):343-9. doi: 10.1001/archneur.64.3.noc60123. Epub 2007 Jan 8.
Godbolt AK, Cipolotti L, Anderson VM, Archer H, Janssen JC, Price S, Rossor MN, Fox NC. A decade of pre-diagnostic assessment in a case of familial Alzheimer's disease: tracking progression from asymptomatic to MCI and dementia. Neurocase. 2005 Feb;11(1):56-64. doi: 10.1080/13554790490896866.
Morris JC, McKeel DW Jr, Storandt M, Rubin EH, Price JL, Grant EA, Ball MJ, Berg L. Very mild Alzheimer's disease: informant-based clinical, psychometric, and pathologic distinction from normal aging. Neurology. 1991 Apr;41(4):469-78. doi: 10.1212/wnl.41.4.469.
Galvin JE, Powlishta KK, Wilkins K, McKeel DW Jr, Xiong C, Grant E, Storandt M, Morris JC. Predictors of preclinical Alzheimer disease and dementia: a clinicopathologic study. Arch Neurol. 2005 May;62(5):758-65. doi: 10.1001/archneur.62.5.758.
Public notes

Contacts
Principal investigator
Name 0 0
Randall J. Bateman, MD
Address 0 0
Washington University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alisha Daniels, MD,MHA
Address 0 0
Country 0 0
Phone 0 0
(314) 273-9057
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00869817