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

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ClinicalTrials.gov Identifier: NCT03849417
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment
Depression Other: ECT

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET-MRI Biomarkers of Pathological Brain Aging in Late-life Depression
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
ECT administered as part of normal clinical management

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



Primary Outcome Measures :
  1. Relationship between synaptic density and hippocampal volume in LLD [ Time Frame: 1 day ]
    Cross-sectional association between [11C]UCB-J binding (SUVR) and MRI-based assessment of hippocampal volume

  2. Relationship between tau and hippocampal volume in LLD [ Time Frame: 1 day ]
    Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume

  3. Relationship between tau and white matter (wm) pathology in LLD [ Time Frame: 1 day ]
    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)

  4. Effect of tau on medial temporal neural responses to emotional stimuli and functional connectivity in LLD [ Time Frame: 1 day ]
    Cross-sectional association between [18F]MK-6240 binding (SUVR), fMRI based assessment of the emotion positivity effect, and fMRI derived resting state brain networks.

  5. Relationship between medial temporal pathology and stress [ Time Frame: 1 week ]
    Association between [18F]MK-6240 binding (SUVR), hippocampal volume (MRI) and reactivity to stress (EMA) and wristband monitoring of heart rate and skin conductance.

  6. Relationship between hippocampal volume increase following ECT and changes in synaptic density and tau [ Time Frame: 8 weeks ]
    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

  7. Amyloid changes following ECT [ Time Frame: 8 weeks ]
    Change in [18F] Flutemetamol one week following the last ECT treatment


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849417


Contacts
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Contact: Mathieu Vandenbulcke, MD, PhD +32 16 3 48005 mathieu.vandenbulcke@uzleuven.be
Contact: Filip Bouckaert, MD, PhD +32 2 758 0891 filip.bouckaert@upckuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium
Contact: Mathieu Vandenbulcke, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Mathieu Vandenbulcke, MD, PhD UZ Leuven / UPC-KU Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03849417     History of Changes
Other Study ID Numbers: S61968
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The nature of anonymized IPD data that may be made available will be determined on an ad hoc basis and in adherence with the terms of the informed consent provided by the participants and advice from the local ethics committees and university technology transfer office.
Keywords provided by Universitaire Ziekenhuizen Leuven:
Late-life depression
Electroconvulsive therapy
Neuroimaging
Aging
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders