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
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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 |
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
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Procedure: lumbar puncture (LP) Procedure: brain MRI |
Patients without cognitive disorders
lumbar punction + brain MRI
|
Procedure: lumbar puncture (LP) Procedure: brain MRI |
- 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.

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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
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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

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 ClinicalTrials.gov identifier (NCT number): NCT02836054
Contact: Lora COHEN | 0476765790/0476769284 | LCohen@chu-grenoble.fr |
France | |
University Hospital, Grenoble | Recruiting |
Grenoble, Isère, France, 38043 | |
Principal Investigator: Lora COHEN | |
Sub-Investigator: Thierry BOUGEROL | |
Sub-Investigator: Olivier Moreaud |
Principal Investigator: | Lora COHEN | CMRR, Pavillon de Neurologie, C.H.U. de Grenoble |
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov 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 |
biomarkers CSF MRI |
Alzheimer's disease bipolar disorder cognitive functions |
Alzheimer Disease Bipolar Disorder Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Bipolar and Related Disorders |