Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

NCT02836054 | Unknown

• 2 other identifiers: 38RC13.4082013-A00930-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Patients with cognitive disorders

OTHER

lumbar punction + brain MRI

Procedure: lumbar puncture (LP); Procedure: brain MRI

Patients without cognitive disorders

OTHER

lumbar punction + brain MRI

Procedure: lumbar puncture (LP); Procedure: brain MRI

Interventions

lumbar puncture (LP) PROCEDURE

Patients with cognitive disorders; Patients without cognitive disorders

brain MRI PROCEDURE

Patients with cognitive disorders; Patients without cognitive disorders

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• distribution in the "with cognitive disorder" or "without cognitive disorder" group is function of the result of the neuropsychological evaluation
• severe visual or auditory disorder
• advanced lumbar osteoarthritis
• history of severe head injury, neurological disorders, diagnosed dementia

You may not qualify if:

• \- at least one of the outcome measures can't be performed :
• MRI
• LP : anticoagulation, bad accessibility

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital, Grenoble

Grenoble, Isère, 38043, France

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Bipolar Disorder; Alzheimer Disease

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lora COHEN

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lora COHEN

CONTACT

0476765790/0476769284; LCohen@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: July 18, 2016
• Study Start: November 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

FR (1)