Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03430869 |
Other study ID # |
201601655A0 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
March 23, 2018 |
Est. completion date |
December 31, 2021 |
Study information
Verified date |
July 2021 |
Source |
Chang Gung Memorial Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Visit 1, Screening assessments (Day 1)
The purpose is to determine eligibility for the proposed study. Screening period may take
place over several days to one week after the first visit. Screening assessments will
include:
1. Study explanations and obtainment of informed consent;
2. Inclusion and exclusion Criteria;
3. Demographics, medical history, and concomitant medications;
4. Clinical characteristic of MDD;
5. Safety measurements include vital sign, ECGs and laboratory tests. In addition, a
pregnancy test will be performed at screening for females who are of childbearing
potential (not for subjects with postmenopause period). A resting ECG and laboratory
tests will be taken during the period of the study visit or had been done within 3
months before study visit.
6. Fertile females must avoid becoming pregnant 30 days after administration of F-18 AV-45
and 18F-THK-5351.The investigators will advise fertile females to use adequate
contraceptive methods during this period, e.g., established use of oral, injected or
implanted hormonal methods of contraception; placement of an intrauterine device (IUD)
or intrauterine system (IUS); barrier methods: condom with spermicidal
foam/gel/film/cream or occlusive cap(diaphragm or cervical/vault caps) with spermicidal
foam /gel /film /cream. In addition, a pregnancy test will be performed at screening for
females who are of childbearing potential (the test must be negative).This test is not
applicable for female subjects with postmenopausal period; permanently sterilized (eg,
bilateral tubal occlusion [which includes tubal ligation procedures as consistent with
local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or
otherwise be incapable of pregnancy.
7. Cognitive function assessment includes MMSE, CDR and comprehensive neurocognitive
battery.
Visit 2, Image study (Month 1±14 days) F-18 AV-45 PET study will be conducted for all
subjects. PET data will be acquired using SIMENS PET/CT or PET/MRI scanner. For PET/CT
protocol, a dynamic brain PET scan will be started simultaneously with the injection of F-18
AV-45 PET after a low-dose CT scan for patient positioning and attenuation correction.
Instead of PET/CT, the investigators will also consider PET/MRI for better soft tissue
contrast and limited radiation exposure for multiple scan session. However, the attenuation
map delineated from MRI is not consistent, and the delicate PET/MRI protocol is still under
evaluation. Vital sign will be checked before and at the end of the image study for all
subjects. Subjects will be continuously observed for signs of adverse events or serious
adverse events. Each study participant (or their caregiver if applicable) will be contacted
by phone approximately 7-14 days after the PET imaging study or at the next follow-up visit
of outpatient department to confirm their well-being and query them about any new adverse
events. Study-emergent AEs will be monitored till resolution or relatively stable state.
Visit 3, Image study (Month 1±14 days) All participants will receive F-18-THK-5351 PET image
study. PET data will be acquired using SIMENS PET/CT or PET/MRI scanner. For PET/CT protocol,
a dynamic brain PET scan will be started simultaneously with the injection of F-18-THK-5351
after a low-dose CT scan for patient positioning and attenuation correction. Instead of
PET/CT, the investigators will also consider PET/MRI for better soft tissue contrast and
limited radiation exposure for multiple scan session. However, the attenuation map delineated
from MRI is not consistent, and the delicate PET/MRI protocol is still under evaluation.
Vital sign will be checked before and after the image study. Safety measurements include ECG,
and clinical labs will be performed at the end of the image study for all subjects. Subjects
will be continuously observed for signs of adverse events or serious adverse events. Each
study participant (or their caregiver if applicable) will be contacted by phone approximately
7-14 days after the PET imaging study or at the next follow-up visit of outpatient department
to confirm their well-being and query them about any new adverse events. Study-emergent AEs
will be monitored till resolution or relatively stable state.