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Completed

NCT Number: NCT01528241

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

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

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABP688

Drug

Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2012
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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