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Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02836054
Acronym
BPL-1318
Enrollment
30
Registered
2016-07-18
Start date
2013-11-30
Completion date
2019-12-31
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Alzheimer's Disease

Keywords

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

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.

Interventions

PROCEDUREbrain MRI

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
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 concentration3 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.

Countries

France

Contacts

Primary ContactLora COHEN
LCohen@chu-grenoble.fr0476765790/0476769284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026