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

Grenoble Alpes University Hospital Center (CHU) logo

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)

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

Trial contacts and locations

1

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Central trial contact

COHEN CL Lora, Doctor

Data sourced from clinicaltrials.gov

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