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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Alzheimer Disease; Tau Proteins; Mild Cognitive Impairment; Senile Plaques; Bipolar Disorders

Treatments: Genetic: Apolipoprotein (ApoE) detection; Other: Psychiatric tests; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Procedure: Lombar Punction; Other: Neuropsychological Tests

Study type: Interventional

Funder types: Other

Identifiers

NCT02843906

38RC13.217

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

BD/CD +

Active Comparator group

Description:

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Treatment:

Radiation: Magnetic Resonance Imaging (MRI)

Radiation: Positron-Emission Tomography (TEP) /(FDG)

Genetic: Apolipoprotein (ApoE) detection

Other: Psychiatric tests

Procedure: Lombar Punction

Other: Neuropsychological Tests

BD/CD -

Active Comparator group

Description:

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Treatment:

Radiation: Magnetic Resonance Imaging (MRI)

Radiation: Positron-Emission Tomography (TEP) /(FDG)

Genetic: Apolipoprotein (ApoE) detection

Other: Psychiatric tests

Procedure: Lombar Punction

Other: Neuropsychological Tests

a-MCI

Active Comparator group

Description:

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Treatment:

Radiation: Magnetic Resonance Imaging (MRI)

Radiation: Positron-Emission Tomography (TEP) /(FDG)

Genetic: Apolipoprotein (ApoE) detection

Other: Psychiatric tests

Procedure: Lombar Punction

Other: Neuropsychological Tests