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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02843906
Acronym
BIPAGE
Enrollment
180
Registered
2016-07-26
Start date
2015-07-31
Completion date
2018-07-31
Last updated
2016-07-26

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

Conditions

Alzheimer Disease, Bipolar Disorders, Mild Cognitive Impairment, Senile Plaques, Tau Proteins

Keywords

alzheimer disease, bipolar disorders, mild cognitive impairement

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.

Interventions

PROCEDURELombar Punction

cerebrospinal fluid testing at screening and M36

RADIATIONMagnetic Resonance Imaging (MRI)

MRI done at screening and M36

RADIATIONPositron-Emission Tomography (TEP) /(FDG)

TEP/FDG done at screening and M36

OTHERPsychiatric tests
OTHERNeuropsychological Tests

done at screening, M12, M24 and M36

GENETICApolipoprotein (ApoE) detection

ApoE detection done at screening

Sponsors

University Hospital, Tours
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
University Hospital, Marseille
CollaboratorOTHER
Hospices Civils de Lyon
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
CollaboratorOTHER
Central Hospital, Nancy, France
CollaboratorOTHER
University Hospital, Clermont-Ferrand
CollaboratorOTHER
Versailles Hospital
CollaboratorOTHER
University Hospital, Montpellier
CollaboratorOTHER
Reims University hospital
CollaboratorOTHER
Centre Hospitalier Princesse Grace
CollaboratorOTHER
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 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

Design outcomes

Primary

MeasureTime frameDescription
Functionnal/Cognitive evaluationHalf an hourGlobal cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Psychatric evaluation15 minutesSemi-directive psychiatric interview.
Brain MRI40 minutesEnable neuropsychological evaluation.

Countries

France

Contacts

Primary ContactCOHEN CL Lora, Doctor
lcohen@chu-grenoble.fr33476766089

Outcome results

None listed

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