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Clinical Trials/NCT02836054
NCT02836054
Unknown
Not Applicable

Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

University Hospital, Grenoble1 site in 1 country30 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
University Hospital, Grenoble
Enrollment
30
Locations
1
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
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Exclusion Criteria

  • at least one of the outcome measures can't be performed :
  • LP : anticoagulation, bad accessibility

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.

Study Sites (1)

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