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

Primary Purpose

Bipolar Disorder, Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

lumbar puncture (LP)

brain MRI

About this trial

This is an interventional screening trial for Bipolar Disorder focused on measuring biomarkers, CSF, MRI, Alzheimer's disease, bipolar disorder, cognitive functions

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital, GrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Patients with cognitive disorders

Patients without cognitive disorders

Arm Description

lumbar punction + brain MRI

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02836054

First Posted

September 20, 2013

Last Updated

January 4, 2019

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT02836054

Brief Title

Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Acronym

BPL-1318

Official Title

Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Alzheimer's Disease

Keywords

biomarkers, CSF, MRI, Alzheimer's disease, bipolar disorder, cognitive functions

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with cognitive disorders

Arm Type

Other

Arm Description

lumbar punction + brain MRI

Arm Title

Patients without cognitive disorders

Arm Type

Other

Arm Description

lumbar punction + brain MRI

Intervention Type

Procedure

Intervention Name(s)

lumbar puncture (LP)

Intervention Type

Procedure

Intervention Name(s)

brain MRI

Primary Outcome Measure Information:

Title

Description

Time Frame

3 hours 50 minutes (total of the 4 primary outcome measures described)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lora COHEN

Phone

0476765790/0476769284

LCohen@chu-grenoble.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lora COHEN

Organizational Affiliation

CMRR, Pavillon de Neurologie, C.H.U. de Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital, Grenoble

City

Grenoble

State/Province

Isère

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lora COHEN

First Name & Middle Initial & Last Name & Degree

Thierry BOUGEROL

First Name & Middle Initial & Last Name & Degree

Olivier Moreaud

12. IPD Sharing Statement

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Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

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