Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Study Overview
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Brief Summary
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Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40 and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar disorder, after an evaluation of their cognitive functions. Comparison between two groups of patients : patients with cognitive disorders and patients without cognitive disorders. The objective is to describe and compare the profile of those biomarkers in those two populations.

Detailed Description
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Describe the profile of the 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in the cerebrospinal fluid (Total Tau proteins, phosphorylated, Aß40 and Aß1-42) for old subjects suffering from bipolar disorder with or without cognitive impairment.

Official Title
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Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Conditions
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Bipolar Disorder, Alzheimer's Disease

Intervention / Treatment
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* Procedure: lumbar puncture (LP)
* Procedure: brain MRI


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with cognitive disorders<br>lumbar punction + brain MRI | Procedure: lumbar puncture (LP)<br> <br> Procedure: brain MRI<br> <br> |
| Other: Patients without cognitive disorders<br>lumbar punction + brain MRI | Procedure: lumbar puncture (LP)<br> <br> Procedure: brain MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The mean concentration of each biomarker is measured independently. The analysis between the 2 groups is done with the profile of the 4 biomarkers, not only between the profile of one biomarker to another. | 3 hours 50 minutes (total of the 4 primary outcome measures described) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers, CSF, MRI, Alzheimer's disease, bipolar disorder, cognitive functions