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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Alzheimer's Disease Procedure: lumbar puncture (LP) Procedure: brain MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Study Start Date : November 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Patients with cognitive disorders
lumbar punction + brain MRI
Procedure: lumbar puncture (LP)
Procedure: brain MRI
Patients without cognitive disorders
lumbar punction + brain MRI
Procedure: lumbar puncture (LP)
Procedure: brain MRI

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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 :

  • MRI
  • LP : anticoagulation, bad accessibility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02836054

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Contact: Lora COHEN 0476765790/0476769284

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University Hospital, Grenoble Recruiting
Grenoble, Isère, France, 38043
Principal Investigator: Lora COHEN         
Sub-Investigator: Thierry BOUGEROL         
Sub-Investigator: Olivier Moreaud         
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Lora COHEN CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
Augy Jennifer, Enjeux cliniques et évolutifs des troubles bipolaires. A partir d'une étude sur l'évaluation cognitive de patients bipolaires vieillissants. Thèse d'exercice. 2010.

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Responsible Party: University Hospital, Grenoble Identifier: NCT02836054    
Other Study ID Numbers: 38RC13.408
2013-A00930-45 ( Other Identifier: ID RCB )
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by University Hospital, Grenoble:
Alzheimer's disease
bipolar disorder
cognitive functions
Additional relevant MeSH terms:
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Alzheimer Disease
Bipolar Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Bipolar and Related Disorders