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

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)

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: ABP688

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States
      • Novartis Investigative Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binding of [11C] ABP688 to mGlu5 receptors	Binding of [11C]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes	Day 1
Blood levels of [11C] ABP688	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.	Day 1, up to 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in [11C]ABP688 binding to mGlu5 receptors	Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients.	Day 1

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CABP688A2102 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Depression; Tracer; ABP688
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: CABP688A2102