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

NCT01548937 | Completed Phase 2 DMC

• 1 other identifier: 98-2132A
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melancholia

Keywords

I-123 ADAM Serotonin transporter imaging

Outcome Measures

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.

  three years

Secondary Outcomes (1)

• Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.

  three years

Study Arms (1)

I-123 ADAM

EXPERIMENTAL

I-123 ADAM Serotonin transporter imaging

Drug: I-123 ADAM

Interventions

I-123 ADAM DRUG

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.

I-123 ADAM

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: March 8, 2012
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 28, 2016

Record last verified: 2016-01