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ISRCTN
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ISRCTN26135594
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ClinicalTrials.gov identifier
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Public title
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Observation of genotype-phenotype interaction effects on white matter in Alzheimer Disease and Bipolar Disorder
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Scientific title
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Observation of genotype-phenotype interaction effects on white matter in Alzheimer Disease and Bipolar Disorder: a cross-sectional cohort study
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Acronym
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N/A
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Serial number at source
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HS/PI2010001
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Study hypothesis
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1. Neuregulin 1 (NRG-1) might be involved in white matter damage in Bipolar Disorder (BD) and Alzheimer’s Disease (AD)
2. It is possible to discriminate BD and AD from healthy controls using diffusion imaging and machine learning techniques
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Lay summary
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Lay summary under review 1
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Ethics approval
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Ethics Committee CEIC Hospital Santiago, Vitoria, Spain approved on 06/25/2010, ref: HS/PI2010001
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Study design
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Cross-sectional cohort study
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Alzheimer Disease, Bipolar Disorder
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Participants - inclusion criteria
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1. Age over 64 years
2. Fluency in Spanish
3. Signed and dated written informed consent in accordance with local regulations
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Participants - exclusion criteria
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Significant neurological disease other than AD and BD
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Anticipated start date
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01/06/2010
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Anticipated end date
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01/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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300
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Interventions
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The study involves three visits per patient.
Visit 1: The baseline study visit lasts about two hours and includes: interview of patient, demographic data, diagnoses, medications used, and baseline use of health and social services. The diagnoses and medications are confirmed from medical records provided by the couples. At the beginning of the visit the patients and caregivers are given written and oral information of the study and informed consent for participation will be obtained from
each subject or an appropriate surrogate (in the case of patients with AD).
Visit 2 (week1): The visit 2 lasts about two hours and includes: Collect blood sample for pharmacogenomic analysis and an evaluation of cognitive, functional, psychological and social domains by:
1. Minimental State Examination (MMSE)
2. Index of Independence in Activities of Daily Living (Katz, Lawton Barthel)
3. Cambridge cognitive examination (CAMCOG)
4. Clinical Dementia Rating (CDR)
5. Global deterioration scale (GDS)
6. Functional Assessment Staging (FAST)
7. Wisconsin (WCST) Trail Making, Stroop, Clock drawing test
8. Positive and negative syndrome scale (PANSS)
9. Young mania rating scale (YMRS)
10. Hamilton rating scale for depression (HDRS)
11. Neuropsychiatric Inventory (NPI).
All caregivers are assessed by the Zarit burden scale.
Visit 3 (week 2): Image Acquisition consisting of volumetric and diffusion tensor imaging obtained in onsite MRI scanner.
Imaging data will be processed using FSL software for the computation of Fraction of Anisotropy (FA) and spatial normalization. Image analysis methods would detect white matter (WM) anomalies. Moreover, machine learning techniques for feature extraction and classification will be applied to detect locations of discriminative features in FA data. Results of machine learning on image data will be correlated with genetic data for assessing genotypic influence on WM effects.
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Primary outcome measure(s)
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1. Correlation between neuregulin 1 (NRG-1) expression and white matter effects in AD and/or
BD
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Secondary outcome measure(s)
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2. Machine learning based classification of AD / BD / healthy controls using imaging and genetic
data
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Sources of funding
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1. Basque Government (Spain) - Saiotek Research Funding Program (code SA-2010/00168)
2. Spanish Ministry of Science (MICINN) (Spain) - Non-Oriented Research Program (code TIN2011-23823)
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Trial website
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Publications
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Contact name
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Dr
Ariadna
Besga
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Address
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Hospital Santiago
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City/town
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Vitoria
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Zip/Postcode
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01004
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Country
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Spain
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Sponsor
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Santiago Hospital (Hospital de Santiago) (Spain)
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Address
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Olaguíbel, 27
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City/town
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Vitoria
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Zip/Postcode
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01004
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Country
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Spain
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Date applied
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15/01/2012
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Last edited
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27/01/2012
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Date ISRCTN assigned
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27/01/2012
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