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

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.

Study Overview

• Status: Completed
• Conditions: Melancholia
• Intervention / Treatment: Drug: I-123 ADAM

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: I-123 ADAM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three years

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (ESTIMATE): March 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: I-123 ADAM Serotonin transporter imaging
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurocognitive Disorders; Depressive Disorder; Dementia
• Other Study ID Numbers: 98-2132A