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

January 4, 2019 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • Recruiting
        • University Hospital, Grenoble
        • Principal Investigator:
          • Lora COHEN
        • Sub-Investigator:
          • Thierry BOUGEROL
        • Sub-Investigator:
          • Olivier Moreaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients with cognitive disorders
lumbar punction + brain MRI
Procedure: lumbar puncture (LP)
Procedure: brain MRI
OTHER: Patients without cognitive disorders
lumbar punction + brain MRI
Procedure: lumbar puncture (LP)
Procedure: brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours 50 minutes (total of the 4 primary outcome measures described)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Lora COHEN, CMRR, Pavillon de Neurologie, C.H.U. de Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC13.408
  • 2013-A00930-45 (OTHER: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on lumbar puncture (LP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe