Actively Recruiting

Age: 70Years - 85Years
All Genders
Healthy Volunteers
ID06914284

Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept

Led by Hospital Center Guillaume Régnier · Updated on 2025-04-06

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

H

Hospital Center Guillaume Régnier

Lead Sponsor

R

Rennes University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating apathy-related neurobehavioral markers in elderly individuals aged 70 to 85 years with bipolar disorder. The goal is to identify reliable signs that may predict a higher risk of progressing to dementia by analyzing motor activity, spoken language, and brain changes using MRI. The study compares elderly bipolar disorder patients with healthy volunteers within the same age range to better understand these markers. Participants will wear a wrist actigraph device for 4 full days to record their body movements. After this period, they will have a 45-minute MRI scan that captures various brain features, including degenerative, inflammatory, vascular, and functional connectivity aspects. The MRI includes several imaging techniques such as anatomical 3DT1, multicompartment models like NODDI, 3D FLAIR, arterial spin labeling, and resting-state BOLD. During the study, participants complete three cognitive tasks assessing verbal memory, verbal fluency, and emotional storytelling. Data from the actimeter and MRI are collected and securely stored for analysis. Researchers will compare actigraphy data from bipolar participants with healthy controls over four days. Speech biomarkers and MRI-derived brain features will also be studied at baseline and at follow-up intervals for bipolar participants. The study includes safety monitoring and lasts up to 36 months for some assessments.

CONDITIONS

Brief Title

Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept

Who Can Participate

Age: 70Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 70 and 85 years old, living at home
  • Diagnosis of old age bipolar disorder type 1, type 2, or type 3 according to DSM-5 criteria
  • No major depressive episode or hypomanic state within the last 6 months
  • Ambulatory setting only (able to walk)
  • Successful gait speed test: able to walk 4 meters in 4 seconds
  • Affiliated with a social security regime
  • Provided free, informed, and written consent to participate
Not Eligible

You will not qualify if you...

  • Diagnosis of unipolar depression or recurrent unipolar depression
  • Substance use disorder except dependence on benzodiazepines or z-drugs
  • Major cognitive disorder with significant decline and loss of autonomy
  • History of degenerative neurological disorders such as Alzheimer's disease, fronto-temporal disorders, Lewy Body disease, corticobasal degeneration, supranuclear palsy, or epilepsy
  • History of Parkinson's disease or stroke
  • Severe Parkinsonism (MDS-UPDRS score > 20)
  • Contraindications for MRI such as metallic implants or severe claustrophobia
  • Adults under legal protection or deprived of liberty
  • Hospitalized at the time of inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 5 days

Participants wear a wrist actigraph for 4 full days to collect activity data before undergoing MRI scans.

1 visit to set up the actigraph and 1 visit to return the device and undergo MRI (about 45 minutes)

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Guillaume Regnier

Rennes, Ile Et Vilaine, France, 35000

Actively Recruiting

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Research Team

G

Gabriel RG ROBERT

N

Nathalie AN ALLETON

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Longitudinal Associations of Mental Disorders With Dementia: 30-Year Analysis of 1.7 Million New Zealand Citizens.

Leah S Richmond-Rakerd, Stephanie D'Souza, Barry J Milne...

https://pubmed.ncbi.nlm.nih.gov/35171209

Late-life depression and risk of vascular dementia and Alzheimer's disease: systematic review and meta-analysis of community-based cohort studies.

Breno S Diniz, Meryl A Butters, Steven M Albert...

https://pubmed.ncbi.nlm.nih.gov/23637108

Late-life depression and the risk of dementia in 14 countries: a 10-year follow-up study from the Survey of Health, Ageing and Retirement in Europe.

Jia-Jia Wu, Hui-Xin Wang, Wu Yao...

https://pubmed.ncbi.nlm.nih.gov/32664001