Clinical trial NCT02836054: Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Official title: Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Alzheimer's Disease
Keywords: biomarkers
CSF
MRI
Alzheimer's disease
bipolar disorder
cognitive functions
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 hours 50 minutes (total of the 4 primary outcome measures described)
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
state: Isère
Study officials:
affiliation: CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
name: Lora COHEN
role: PRINCIPAL_INVESTIGATOR
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