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

NCT ID: NCT03849417

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-19

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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This clinical study is a combined single-center, cohort study with a (1) cross-sectional arm evaluating relationships and differences in PET-MR imaging and behavioral measures in 64 patients with late life depression (LLD) compared to 64 healthy controls, and (2) a longitudinal arm evaluating relationships and differences in imaging and behavioral measures in 20 patients receiving ECT as part of their normal clinical management. The study will utilise three PET tracers: (1) \[11C\]UCB-J, which targets the Synaptic Vesicle Glycoprotein 2A receptor, to estimate synaptic density (2) \[18F\]MK-6240, which targets tau associated with neurofibrillary tangles, to assess the presence of tau pathology and (3) \[18F\]-Flutemetamol, which targets beta-amyloid neuritic plaques in the brain, to assess the presence of cerebral amyloidosis. The main aim of the study is to clarify how hippocampal synaptic density, tau, amyloid and white matter lesions, relate to neuropsychological function, stress and ECT in late life depression.

Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Late-life Depression

Patients aged over 60 years old with severe depression

No interventions assigned to this group

Late-life Depression (ECT)

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

ECT

Intervention Type OTHER

ECT administered as part of normal clinical management

Healthy Controls

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

No interventions assigned to this group

Interventions

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ECT

ECT administered as part of normal clinical management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu Vandenbulcke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven / UPC-KU Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Mathieu Vandenbulcke, MD, PhD

Role: CONTACT

+32 16 3 48005

Filip Bouckaert, MD, PhD

Role: CONTACT

+32 2 758 0891

Facility Contacts

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Mathieu Vandenbulcke, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40203967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33509135 (View on PubMed)

Other Identifiers

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S61968

Identifier Type: -

Identifier Source: org_study_id

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