Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Bipolar Disorder Clinical Trial

— BPL-1318  

Official title:

Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836054
• Other study ID #: 38RC13.408
• Secondary ID: 2013-A00930-45
• Status: Recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: University Hospital, Grenoble
• Contact: Lora COHEN
• Phone: 0476765790/0476769284
• Email: LCohen[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Bipolar Disorder

Intervention

Procedure:
• lumbar puncture (LP)

• brain MRI

Locations

Country	Name	City	State
France	University Hospital, Grenoble	Grenoble	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (24)

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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.

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. — View Citation

Delaloye 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. — View Citation

Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lövblad 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. — View Citation

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Zetterberg H, Tullhög K, Hansson O, Minthon L, Londos E, Blennow K. Low incidence of post-lumbar puncture headache in 1,089 consecutive memory clinic patients. Eur Neurol. 2010;63(6):326-30. doi: 10.1159/000311703. Epub 2010 Jun 3. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 hours 50 minutes (total of the 4 primary outcome measures described)