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

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ClinicalTrials.gov Identifier: NCT02836054
Recruitment Status : Unknown
Verified January 2019 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : July 18, 2016
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE September 20, 2013
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date January 7, 2019
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Profile 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in cerebrospinal fluid [ Time Frame: 3 hours 50 minutes ]
Total Tau proteins, phosphorylated , Aß40 and Aß1-42
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Official Title  ICMJE Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Bipolar Disorder
  • Alzheimer's Disease
Intervention  ICMJE
  • Procedure: lumbar puncture (LP)
  • Procedure: brain MRI
Study Arms  ICMJE
  • Patients with cognitive disorders
    lumbar punction + brain MRI
    Interventions:
    • Procedure: lumbar puncture (LP)
    • Procedure: brain MRI
  • Patients without cognitive disorders
    lumbar punction + brain MRI
    Interventions:
    • Procedure: lumbar puncture (LP)
    • Procedure: brain MRI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836054
Other Study ID Numbers  ICMJE 38RC13.408
2013-A00930-45 ( Other Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lora COHEN CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
PRS Account University Hospital, Grenoble
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP