Brain Imaging Biomarkers of Pathological Brain Aging in Late-life Depression

NCT03849417 | Unknown

• 1 other identifier: S61968
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. The study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.The data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.

Conditions

Depression

Keywords

Late-life depression; Electroconvulsive therapy; Neuroimaging; Aging

Outcome Measures

Primary Outcomes (7)

• Relationship between synaptic density and hippocampal volume in LLD

  Cross-sectional association between \[11C\]UCB-J binding (SUVR) and MRI-based assessment of hippocampal volume

  1 day

• Relationship between tau and hippocampal volume in LLD

  Cross-sectional association between \[18F\]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume

  1 day

• Relationship between tau and white matter (wm) pathology in LLD

  Cross-sectional association between \[18F\]MK-6240 binding (SUVR) and MRI measures of white matter pathology (T2-FLAIR WMH/lesions, diffusion MRI measures in temporal lobe tracts)

  1 day

• Effect of tau on medial temporal neural responses to emotional stimuli and functional connectivity in LLD

  Cross-sectional association between \[18F\]MK-6240 binding (SUVR), fMRI based assessment of the emotion positivity effect, and fMRI derived resting state brain networks.

  1 day

• Relationship between medial temporal pathology and stress

  Association between \[18F\]MK-6240 binding (SUVR), hippocampal volume (MRI) and reactivity to stress (EMA) and wristband monitoring of heart rate and skin conductance.

  1 week

• Relationship between hippocampal volume increase following ECT and changes in synaptic density and tau

  Association between change in \[11C\]UCB-J and \[18F\]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume one week following last ECT

  8 weeks

• Amyloid changes following ECT

  Change in \[18F\] Flutemetamol one week following the last ECT treatment

  8 weeks

Study Arms (3)

Late-life Depression

Patients aged over 60 years old with severe depression

Late-life Depression (ECT)

Patients aged over 60 years old with severe depression who are referred for treatment with electroconvulsive therapy

Other: ECT

Healthy Controls

Healthy volunteers over 60 years old who will form a comparison group

Interventions

ECT OTHER

ECT administered as part of normal clinical management

Late-life Depression (ECT)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A consecutive series of hospital in-patients with late-life depression will be recruited from the Department of Old Age Psychiatry within the University Psychiatric Center, KU Leuven, Belgium. Healthy controls will be recruited from the community by researchers affiliated with the Department of Old Age Psychiatry Department \& Translational Neuropsychiatry using traditional means e.g. flyer. All participants will provide written informed consent prior to enrollment in the study in accordance with the Declaration of Helsinki.

You may qualify if:

• Diagnosis of late-life depression according to DSM 5 (patients only)
• Age over 60 years old
• Judged to be in good physical health by the investigator on the basis of medical history

You may not qualify if:

• history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only).
• history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer);
• current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse;
• had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months;
• has a contra-indication for MRI scanning;
• suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; cannot lie still for 60 minutes inside the scanner;
• does not understand the study procedures
• unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;
• underwent ECT within the last 3 months before enrollment (patients)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (2)

• Van Cauwenberge MGA, Vande Casteele T, Laroy M, Vansteelandt K, Van den Stock J, Bouckaert F, Emsell L, Vandenbulcke M. Motor dysfunction in late life depression: A mood or movement disorder? J Affect Disord. 2025 Jul 15;381:680-691. doi: 10.1016/j.jad.2025.04.053. Epub 2025 Apr 9.

  PMID: 40203967 DERIVED

• Emsell L, Laroy M, Van Cauwenberge M, Vande Casteele T, Vansteelandt K, Van Laere K, Sunaert S, Van den Stock J, Bouckaert F, Vandenbulcke M. The Leuven late life depression (L3D) study: PET-MRI biomarkers of pathological brain ageing in late-life depression: study protocol. BMC Psychiatry. 2021 Jan 28;21(1):64. doi: 10.1186/s12888-021-03063-y.

  PMID: 33509135 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mathieu Vandenbulcke, MD, PhD

  UZ Leuven / UPC-KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu Vandenbulcke, MD, PhD

CONTACT

+32 16 3 48005; mathieu.vandenbulcke@uzleuven.be

Filip Bouckaert, MD, PhD

CONTACT

+32 2 758 0891; filip.bouckaert@upckuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: June 19, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2023-11

Locations

BE (1)