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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01548937

First received: December 29, 2011

Last updated: March 6, 2012

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 29, 2011
Last Updated Date	March 6, 2012
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2012)	Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia. [ Time Frame: three years ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01548937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2012)	Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter. [ Time Frame: three years ] [ Designated as safety issue: Yes ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Serotonin Transporter Density in Late-life Depression With and Without Dementia
Official Title ^ICMJE	Serotonin Transporter Density in Late-life Depression With and Without Dementia
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Melancholia
Intervention ^ICMJE	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. Other Name: I-123 ADAM
Study Arm (s)	Experimental: I-123 ADAM I-123 ADAM Serotonin transporter imaging Intervention: Drug: I-123 ADAM
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2012
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01548937
Other Study ID Numbers ^ICMJE	98-2132A
Has Data Monitoring Committee	Yes
Responsible Party	Chang Gung Memorial Hospital
Study Sponsor ^ICMJE	Chang Gung Memorial Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chang Gung Memorial Hospital
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top