Bipolar DisorderBPL-1318NCT02836054
Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
A study testing lumbar puncture (LP) and brain MRI in people with Bipolar Disorder and Alzheimer's Disease, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Bipolar Disorder, Alzheimer's Disease
- What is being tested?
- lumbar puncture (LP) and brain MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- at least one of the outcome measures can't be performed :
- MRI
- LP : anticoagulation, bad accessibility
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Grenoble
Grenoble, Isère, 38043
Lora COHEN
Thierry BOUGEROL
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder, Alzheimer's Disease
- Being tested
- lumbar puncture (LP), brain MRI
- Keywords
- biomarkers, CSF, MRI, Alzheimer's disease, bipolar disorder, cognitive functions
- Medical subject headings
- Bipolar Disorder, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar puncture (LP)Procedure or surgery
brain MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with cognitive disorders | Other | lumbar punction + brain MRI Receives: Procedure: lumbar puncture (LP); Procedure: brain MRI |
| Patients without cognitive disorders | Other | lumbar punction + brain MRI Receives: Procedure: lumbar puncture (LP); Procedure: brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours 50 minutes (total of the 4 primary outcome measures described)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lora COHEN, Principal investigator, CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836054
- Sponsor's protocol ID
- 38RC13.408
- Other IDs
- 2013-A00930-45
- Acronym
- BPL-1318
- Status last verified
- Jan 2019
- First submitted
- 20 Sep 2013
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.
PubMed 11725216Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.
PubMed 19067364Augy 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.
Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6. doi: 10.1111/j.1600-0447.2005.00570.x.
PubMed 15992392Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.
PubMed 19719786Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.
PubMed 21394788Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.
PubMed 21563239Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12. doi: 10.1212/01.wnl.0000286944.22262.ff.
PubMed 18071141Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.
PubMed 20049742Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11. doi: 10.1111/j.1600-0404.1995.tb07029.x.
PubMed 7639073Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9. doi: 10.1016/s0165-0327(02)00004-6.
PubMed 12547295Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6. doi: 10.1136/jnnp.2003.031773.
PubMed 15548477Li G, Sokal I, Quinn JF, Leverenz JB, Brodey M, Schellenberg GD, Kaye JA, Raskind MA, Zhang J, Peskind ER, Montine TJ. CSF tau/Abeta42 ratio for increased risk of mild cognitive impairment: a follow-up study. Neurology. 2007 Aug 14;69(7):631-9. doi: 10.1212/01.wnl.0000267428.62582.aa.
PubMed 17698783Martino DJ, Igoa A, Marengo E, Scapola M, Ais ED, Strejilevich SA. Cognitive and motor features in elderly people with bipolar disorder. J Affect Disord. 2008 Jan;105(1-3):291-5. doi: 10.1016/j.jad.2007.05.014. Epub 2007 Jun 18.
PubMed 17573121Meeks S. Bipolar disorder in the latter half of life: symptom presentation, global functioning and age of onset. J Affect Disord. 1999 Jan-Mar;52(1-3):161-7. doi: 10.1016/s0165-0327(98)00069-x.
PubMed 10357029
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
- ClinicalTrials.gov ID
- NCT02836054
- Acronym / sponsor ID
- BPL-1318 / 38RC13.408
- Conditions
- Bipolar Disorder, Alzheimer's Disease
- Keywords
- biomarkers, CSF, MRI, Alzheimer's disease, bipolar disorder, cognitive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cognitive disorders | Other | Procedure: lumbar puncture (LP), Procedure: brain MRIlumbar punction + brain MRI |
| Patients without cognitive disorders | Other | Procedure: lumbar puncture (LP), Procedure: brain MRIlumbar punction + brain MRI |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (3 listed)
- at least one of the outcome measures can't be performed :
- MRI
- LP : anticoagulation, bad accessibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar puncture (LP) | Procedure or surgery | Patients with cognitive disorders, Patients without cognitive disorders |
| brain MRI | Procedure or surgery | Patients with cognitive disorders, Patients without cognitive disorders |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Background: PubMed 11725216Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.
- Background: PubMed 19067364Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.
- BackgroundAugy 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.
- Background: PubMed 15992392Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6. doi: 10.1111/j.1600-0447.2005.00570.x.
- Background: PubMed 19719786Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.
- Background: PubMed 21394788Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.
- Background: PubMed 21563239Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.
- Background: PubMed 18071141Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12. doi: 10.1212/01.wnl.0000286944.22262.ff.
- Background: PubMed 20049742Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.
- Background: PubMed 7639073Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11. doi: 10.1111/j.1600-0404.1995.tb07029.x.
- Background: PubMed 12547295Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9. doi: 10.1016/s0165-0327(02)00004-6.
- Background: PubMed 15548477Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6. doi: 10.1136/jnnp.2003.031773.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora COHEN principal investigator
CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar puncture (LP) and brain MRI in people with Bipolar Disorder and Alzheimer's Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lora COHEN (0476765790/0476769284, LCohen@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836054, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.