Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Not Applicable

• Conditions: Bipolar Disorder; Alzheimer's Disease
• Interventions: Procedure: lumbar puncture (LP); Procedure: brain MRI

• Registration Number: NCT02836054
• Lead Sponsor: University Hospital, Grenoble

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 Timeline

• Study First Submitted: 2013-09-20
• Study Start: 2013-11
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without cognitive disorders	brain MRI	lumbar punction + brain MRI
Patients with cognitive disorders	brain MRI	lumbar punction + brain MRI
Patients without cognitive disorders	lumbar puncture (LP)	lumbar punction + brain MRI
Patients with cognitive disorders	lumbar puncture (LP)	lumbar punction + brain MRI

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University Hospital, Grenoble; 🇫🇷 Grenoble, Isère, France