Clinical trial NCT02843906: Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
Official title: Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Senile Plaques
Tau Proteins
Alzheimer Disease
Bipolar Disorders
Mild Cognitive Impairment
Keywords: alzheimer disease
bipolar disorders
mild cognitive impairement
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
name: Assistance Publique - Hôpitaux de Paris
name: University Hospital, Marseille
name: Hospices Civils de Lyon
name: Centre Hospitalier Universitaire de Besancon
name: Central Hospital, Nancy, France
name: University Hospital, Clermont-Ferrand
name: Versailles Hospital
name: University Hospital, Montpellier
name: Reims University hospital
name: Centre Hospitalier Princesse Grace
First posted: 2016-07-26
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functionnal/Cognitive evaluation
timeFrame: Half an hour
measure: Psychatric evaluation
timeFrame: 15 minutes
measure: Psychatric evaluation
timeFrame: 15 minutes
measure: Brain MRI
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital, Tours
Study officials:
affiliation: University Hospital, Grenoble
name: BOUGEROL BT Thierry, Professor
role: PRINCIPAL_INVESTIGATOR
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