Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 :
- •LP : anticoagulation, bad accessibility
Arms & Interventions
Patients with cognitive disorders
lumbar punction + brain MRI
Intervention: lumbar puncture (LP) (Procedure)
Patients with cognitive disorders
lumbar punction + brain MRI
Intervention: brain MRI (Procedure)
Patients without cognitive disorders
lumbar punction + brain MRI
Intervention: brain MRI (Procedure)
Patients without cognitive disorders
lumbar punction + brain MRI
Intervention: lumbar puncture (LP) (Procedure)
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
No secondary outcomes reported