A Phase 2 interventional study of I-123 ADAM in Melancholia, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Diagnostic
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
This study is expected to be completed in a period of 3 years.
Depression and dementia are the two common psychiatric disorders in the elder subjects. Alzheimer's disease (AD) is the most frequent cause of dementia and about 20% of them have depression. Depression subjects are associated with more rapid cognitive decline, a poorer response to treatment. Post mortem study showed close relationship between AD and disruptions of the serotonergic system, including loss of serotnergic neurons at brain stem. However, the alternations in presynaptic serotonin function relative to demented or non-demented subjects remain to be investigated in living subjects. In this study, the investigators will collect 40 elder subjects (i.e., age above or equal to 50 years old). The serotonin transporter activity will be compared between subjects with or without dementia using I-123 ADAM images. The single photon emission tomography (SPECT) will be compared to recent (within 6 months) F-18 FDG PET images for further investigation.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 39 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients may be enrolled in the AD depressive group if they:
Patients may be enrolled in the cognitively depressive group if they:
Exclusion Criteria:
I-123 ADAM Serotonin transporter imaging
Drug: I-123 ADAM
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia.
To expand the database of I-123 ADAM SPECT imaging in AD depressive and cognitively depressive patients to refine the definition of a positive scan in patient with AD and MDD.
Time frame: three years
Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.
To expand the safety database of I-123 ADAM SPECT imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate.
Time frame: three years
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital