Study of Degenerescence CSF Hallmarks in Older Bipolar Patients (BPL-1318)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Alzheimer's Disease; Bipolar Disorder

Treatments: Procedure: brain MRI; Procedure: lumbar puncture (LP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02836054

2013-A00930-45 (Other Identifier)

38RC13.408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Patients with cognitive disorders

Other group

Description:

lumbar punction + brain MRI

Treatment:

Procedure: brain MRI

Procedure: lumbar puncture (LP)

Patients without cognitive disorders

Other group

Description:

lumbar punction + brain MRI

Treatment:

Procedure: brain MRI

Procedure: lumbar puncture (LP)