CClinicalTrials.gg
CompletedNCT01548937Updated Jan 28, 2016

Serotonin Transporter Density in Late-life Depression With and Without Dementia

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

Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Melancholia

Keywords

  • I-123 ADAM Serotonin transporter imaging
03

In context

Dementia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients may be enrolled in the AD depressive group if they:

    • Are males or females at least 50 years of age;
    • Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
    • Meet the NINCDS/ADRDA(National institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association) criteria for probable AD
    • A Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
    • Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
  2. Patients may be enrolled in the cognitively depressive group if they:

    • Are males or females at least 50 years of age;
    • Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
    • Memory function above the lower normal limits (i.e. 1.5 SD above the mean) on tests for episodic memory.
    • Clinical Dementia Rating = 0. Memory Box score must be 0.
    • Cognitively normal, based on an absence of significant impairment in cognitive functions or ADL.
    • A MMSE score at screening > 24 for those with education level of 6 years or above and > 17 for those are illiterate;
    • Give informed consent.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
  • Conditions affecting brain structure or function (e.g., stroke, diabetes, head trauma, depression) or use of cognitively
  • Substance abuse.
  • Alcohol dependence
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    I-123 ADAM

    I-123 ADAM Serotonin transporter imaging

    Drug: I-123 ADAM

Interventions

  • DrugI-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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01548937
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
May 2010
Primary completion
Oct 2012
Completion
Dec 2012
Last update
Jan 28, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion