Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528241
First received: February 3, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

This study is designed to characterize the regional distribution of [11C] ABP688 in brain by positron emission tomography (PET).


Condition Intervention Phase
Depression
Drug: ABP688
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multi-center, Open-label Study in Elderly Healthy Volunteers and Elderly Patients With Major Depressive Disorder to Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Binding of [11C] ABP688 to mGlu5 receptors [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Binding of [11C]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes

  • Blood levels of [11C] ABP688 [ Time Frame: Day 1, up to 60 minutes ] [ Designated as safety issue: No ]
    Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of [11C] ABP688. Specific times are recorded at the clinical site.


Secondary Outcome Measures:
  • Difference in [11C]ABP688 binding to mGlu5 receptors [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients.


Enrollment: 42
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP688
Elderly MDD patients and demography matched healthy volunteer
Drug: ABP688
Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects 55-80 (inclusive)
  • Subjects in good health

At screening:

  • oral body temperature between 35-37.5C
  • systolic blood pressure: 90-140 mm Hg
  • diastolic blood pressure: 50-90 mm Hg
  • pulse rate: 40-90 bpm
  • Female subjects of child bearing potential must have been using a double-barrier local contraception
  • Postmenopausal women must have had no menstrual bleeding
  • Subjects must have weighed at least 50 kg
  • All subjects must provide informed consent
  • All subjects must have been able to communicate well with investigator

Specific to Major depression disorder (MDD)

Patients had to show following level of symptomatology:

  • HAM-D (17-item scale) > 16
  • CGI > 4 (moderately ill)

Exclusion Criteria:

Specific criteria for healthy volunteers:

- Presence and/or history of clinically significant major neurological or psychiatric disorder

Specific criteria for MDD patients:

  • Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
  • Axis I co-morbidity was excluded except anxiety spectrum disorders

Criteria for both:

  • Smokers
  • Pregnancy
  • Subjects with history of or symptoms/complaints consistent with mild cognitive impairment
  • Use of any psychotropic prescription drugs
  • Coffee consumers more than 6 cups/day
  • Participation in any clinical investigation
  • Donation or loss of 400 mL or more of blood
  • Significant illness within 2 weeks prior to dosing
  • A known hypersensitivity to study drug
  • MRI scan that showed evidence of stroke
  • Any surgical or medical condition which might have significantly altered distribution
  • Clinical evidence of any abnormal lab value
  • History of immunodeficiency disease
  • Positive Hepatitis B surface antigen
  • Presence of contraindications to PET scan investigations- Presence of contraindications to MRI investigations
  • Evidence from an Allen test of incomplete communication
  • History of drug or alcohol abuse
  • Current use of anticonvulsant
  • Significant radiation exposure

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528241

Locations
United States, New York
Novartis Investigative Site
New York, New York, United States
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01528241     History of Changes
Other Study ID Numbers: CABP688A2102
Study First Received: February 3, 2012
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
ABP688
Tracer
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 02, 2014