Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

Study Overview
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Brief Summary
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The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.

Official Title
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Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

Conditions
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Senile Plaques, Tau Proteins, Alzheimer Disease, Bipolar Disorders, Mild Cognitive Impairment

Intervention / Treatment
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* Procedure: Lombar Punction
* Radiation: Magnetic Resonance Imaging (MRI)
* Radiation: Positron-Emission Tomography (TEP) /(FDG)
* Other: Psychiatric tests
* Other: Neuropsychological Tests
* Genetic: Apolipoprotein (ApoE) detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female subject aged between 60 and 80 years old in patient or out-patient at one of the centers participating in the study Mini-mental state examination (MMSE) score > 20 at baseline patient with diagnostic of amnestic-Mild Cognitive Impairment patients suffering of bipolar disorders type I or II in remitted (euthymic) state at baseline Exclusion Criteria: pre-existing history of dementia history of neurologic disorder lifetime history of a severe psychiatric disorder other than bipolar disorders current medical problems patients treated with electroconvulsive therapy within the past six months patients with substance abuse or dependence within the past 12 months patients hospitalized without consent

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 |
| --- | --- |
| Active Comparator: BD/CD +<br>Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests | Procedure: Lombar Punction<br>* cerebrospinal fluid testing at screening and M36<br>Radiation: Magnetic Resonance Imaging (MRI)<br>* MRI done at screening and M36<br>Radiation: Positron-Emission Tomography (TEP) /(FDG)<br>* TEP/FDG done at screening and M36<br>Other: Psychiatric tests<br> <br> Other: Neuropsychological Tests<br>* done at screening, M12, M24 and M36<br>Genetic: Apolipoprotein (ApoE) detection<br>* ApoE detection done at screening<br>|
| Active Comparator: BD/CD -<br>Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests | Procedure: Lombar Punction<br>* cerebrospinal fluid testing at screening and M36<br>Radiation: Magnetic Resonance Imaging (MRI)<br>* MRI done at screening and M36<br>Radiation: Positron-Emission Tomography (TEP) /(FDG)<br>* TEP/FDG done at screening and M36<br>Other: Psychiatric tests<br> <br> Other: Neuropsychological Tests<br>* done at screening, M12, M24 and M36<br>Genetic: Apolipoprotein (ApoE) detection<br>* ApoE detection done at screening<br>|
| Active Comparator: a-MCI<br>Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests | Procedure: Lombar Punction<br>* cerebrospinal fluid testing at screening and M36<br>Radiation: Magnetic Resonance Imaging (MRI)<br>* MRI done at screening and M36<br>Radiation: Positron-Emission Tomography (TEP) /(FDG)<br>* TEP/FDG done at screening and M36<br>Other: Psychiatric tests<br> <br> Other: Neuropsychological Tests<br>* done at screening, M12, M24 and M36<br>Genetic: Apolipoprotein (ApoE) detection<br>* ApoE detection done at screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionnal/Cognitive evaluation | Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL. | Half an hour | 
| Psychatric evaluation | Semi-directive psychiatric interview. | 15 minutes | 
| Psychatric evaluation | Scales for thymus evaluation : GDS, YMRS, BPRS, STAI | 15 minutes | 
| Brain MRI | Enable neuropsychological evaluation. | 40 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alzheimer disease, bipolar disorders, mild cognitive impairement