Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

Not Applicable

• Conditions: Tau Proteins; Alzheimer Disease; Mild Cognitive Impairment; Senile Plaques; Bipolar Disorders
• Interventions: Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection

• Registration Number: NCT02843906
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-05-11
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• male or female subject aged between 60 and 80 years old
• in patient or out-patient at one of the centers participating in the study
• Mini-mental state examination (MMSE) score > 20 at baseline
• patient with diagnostic of amnestic-Mild Cognitive Impairment
• patients suffering of bipolar disorders type I or II
• in remitted (euthymic) state at baseline

Exclusion Criteria

• pre-existing history of dementia
• history of neurologic disorder
• lifetime history of a severe psychiatric disorder other than bipolar disorders
• current medical problems
• patients treated with electroconvulsive therapy within the past six months
• patients with substance abuse or dependence within the past 12 months
• patients hospitalized without consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BD/CD +	Positron-Emission Tomography (TEP) /(FDG)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Psychiatric tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD +	Lombar Punction	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD +	Magnetic Resonance Imaging (MRI)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD +	Neuropsychological Tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Lombar Punction	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Neuropsychological Tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Magnetic Resonance Imaging (MRI)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Lombar Punction	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Psychiatric tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD +	Psychiatric tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD +	Apolipoprotein (ApoE) detection	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Positron-Emission Tomography (TEP) /(FDG)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Magnetic Resonance Imaging (MRI)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Neuropsychological Tests	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Apolipoprotein (ApoE) detection	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Positron-Emission Tomography (TEP) /(FDG)	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Apolipoprotein (ApoE) detection	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Primary Outcome Measures

Name	Time	Method
Functionnal/Cognitive evaluation	Half an hour	Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Psychatric evaluation	15 minutes	Scales for thymus evaluation : GDS, YMRS, BPRS, STAI
Brain MRI	40 minutes	Enable neuropsychological evaluation.

Trial Locations

Locations (1)

University Hospital, Tours; 🇫🇷 Tours, France