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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528241
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Depression Drug: ABP688 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : August 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Binding of [11C] ABP688 to mGlu5 receptors [ Time Frame: Day 1 ]
    Binding of [11C]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes

  2. Blood levels of [11C] ABP688 [ Time Frame: Day 1, up to 60 minutes ]
    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 :
  1. Difference in [11C]ABP688 binding to mGlu5 receptors [ Time Frame: Day 1 ]
    Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528241

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01528241     History of Changes
Other Study ID Numbers: CABP688A2102
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Additional relevant MeSH terms:
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Behavioral Symptoms