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Pathophysiology of Neurodegeneration in Late-life Depression (AV45+THK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430869
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Late-life depression has been frequently associated with cognitive impairment. Several meta-analyses consistently suggested that a history of depression approximately doubles an individual's risk for developing dementia later in life. Neurodegeneration may play an important component in late-life depression. The pathophysiology behind the link between late-life depression and the subsequent development of dementia largely remains unclear, and should be heterogeneous. This highlights the need to identify specific neurodegenerative pathways involved in late-life depression, which will facilitate research on mechanisms and new treatments in the future.

The recently published the National Institute on Aging and the Alzheimer Association (NIA-AA) criteria might provide new insights and frameworks to explore the patterns of neurodegenerative process in elderly depressed patients and to categorize them into different biomarker-based groups. In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18 AV-45 PET, and neurodegeneration (N) was established by measuring hippocampal volume using MRI. Individuals were categorised as A-N-, A+N-, A+N+, or suspected non-Alzheimer's disease pathophysiology (A-N+, SNAP). All subjects will further undergo F-18-THK-5351 image study to detect underlying tau pathology. By doing this, the investigators will elucidate the neurodegenerative pathophysiology behind the link between depressive disorder and the subsequent development of dementia.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: F-18 AV-45 Drug: F-18-THK-5351 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploring and Subtyping the Pathophysiology of Neurodegeneration in Late-life Depression: Implications for Treatment and Prognosis in the Future
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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Arm Intervention/treatment
Experimental: F-18 AV-45
F-18 AV-45 imaging
Drug: F-18 AV-45
In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18 AV-45 PET.

Experimental: F-18-THK-5351
F-18-THK-5351 imaging
Drug: F-18-THK-5351
In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. All subjects will further undergo F-18-THK-5351 image study to detect underlying tau pathology. By doing this, the investigators will elucidate the neurodegenerative pathophysiology behind the link between depressive disorder and the subsequent development of dementia.




Primary Outcome Measures :
  1. The standard uptake value ratio (SUVR) of 18F-florbetapir [ Time Frame: three years ]
    The primary outcome is to measure the standard uptake value ratio (SUVR) of 18F-florbetapir in patients with major depressive disorder and compare the difference between patients and non-depressed subjects. 18F-florbetapir SUVRs of each volume of interest are analyzed using whole the cerebellum as the reference region.


Secondary Outcome Measures :
  1. The standard uptake value ratio (SUVR) of 18F-THK-5351 [ Time Frame: three years ]
    The secondary outcome is to measure the standard uptake value ratio (SUVR) of 18F-THK-5351 in patients with major depressive disorder and compare the difference between patients and non-depressed subjects. 18F-THK-5351 SUVRs of each volume of interest are analyzed using the pons as the reference region.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Enrolled subjects will be 50 to 90 years of age. They should understand the content of consent and sign consent after the explanation of the benefits and possible side effects of this trial
  2. Patients with a clinical diagnosis of major depressive disorder according to the DSM -5 criteria (APA, 2013).
  3. Comparison subjects evaluated for lifetime absence of psychiatric illness by MINI interview (Sheehan et al., 1998).
  4. Fertile females must avoid becoming pregnant and must use adequate contraceptive methods for 30 days after administration of study radiotracer.

Exclusion Criteria:

  1. Any subject has clinically definite diagnosis of dementia before study recruitment according to the NIA-AA criteria for possible or probable clinically-defined AD dementia ( McKhann, 2011) or the DSM -5 criteria for any type of dementia (APA, 2013).
  2. Any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders
  3. Any subject has a current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or epilepsy
  4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or previously prolonged history of substances abuse
  5. Any females who is pregnant or lactating
  6. General MRI, and/or PET exclusion criteria including subjects who are pregnant, or had received brain aneurysm surgery, or implanted pacemaker, mechanical valves or cochlear implant.
  7. Any subjects with history of severe allergic or anaphylactic reactions particularly to the study medication, or any subjects who are recognized as high risk of adverse effects by principle investigator.

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): NCT03430869


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Guishan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: KUAN YI WU Attending physician
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03430869    
Other Study ID Numbers: 201601655A0
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
late-life depression
major depressive disorder
Alzheimer's disease dementia
neurodegeneration
amyloid plague, tau protein
Additional relevant MeSH terms:
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Nerve Degeneration
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes