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

Primary Purpose

Melancholia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
I-123 ADAM
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melancholia focused on measuring I-123 ADAM Serotonin transporter imaging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    I-123 ADAM

    Arm Description

    I-123 ADAM Serotonin transporter imaging

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 29, 2011
    Last Updated
    January 27, 2016
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01548937
    Brief Title
    Serotonin Transporter Density in Late-life Depression With and Without Dementia
    Official Title
    Serotonin Transporter Density in Late-life Depression With and Without Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melancholia
    Keywords
    I-123 ADAM Serotonin transporter imaging

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I-123 ADAM
    Arm Type
    Experimental
    Arm Description
    I-123 ADAM Serotonin transporter imaging
    Intervention Type
    Drug
    Intervention Name(s)
    I-123 ADAM
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia.
    Description
    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 Outcome Measure Information:
    Title
    Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). 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

    12. IPD Sharing Statement

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

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