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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02836054 |
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Date of registration:
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20/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
BPL-1318 |
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Scientific title:
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Study of Degenerescence CSF Hallmarks in Older Bipolar Patients |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02836054 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Lora COHEN |
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Address:
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Telephone:
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0476765790/0476769284 |
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Email:
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LCohen@chu-grenoble.fr |
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Affiliation:
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Name:
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Lora COHEN |
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Address:
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Telephone:
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Email:
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Affiliation:
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CMRR, Pavillon de Neurologie, C.H.U. de Grenoble |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male or female between 60 and 80
- french-speaking, reading and writing patient
- affiliation to the French Social Security
- written informed consent obtained from the patient
- agree to undergo a lumbar puncture
- easy accessibility for the lumbar puncture
- Mini Mental State Examination (MMSE) > 20
- bipolar patients :
- type I or II
- state of euthymia for at least 4 weeks
- stable psychotropic drug treatment for at least 8 weeks
- no electroconvulsive therapy during the 6 months before inclusion
- distribution in the "with cognitive disorder" or "without cognitive disorder" group is
function of the result of the neuropsychological evaluation
Non-inclusion Criteria :
- severe visual or auditory disorder
- advanced lumbar osteoarthritis
- history of severe head injury, neurological disorders, diagnosed dementia
- addiction weaned for less than 12 months
- forced hospitalization in psychiatry
- MRI contraindications
- LP contraindications
Exclusion Criteria:
- at least one of the outcome measures can't be performed :
- MRI
- LP : anticoagulation, bad accessibility
Age minimum:
60 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Bipolar Disorder
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Intervention(s)
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Procedure: brain MRI
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Procedure: lumbar puncture (LP)
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Primary Outcome(s)
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Profile 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in cerebrospinal fluid of aged subjects with bipolar disorder : Total Tau proteins, phosphorylated Tau proteins, Aß40 and Aß1-42 concentration
[Time Frame: 3 hours 50 minutes (total of the 4 primary outcome measures described)]
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Secondary ID(s)
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38RC13.408
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2013-A00930-45
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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