Clinical trial NCT01528241: Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: ABP688
Tracer
Depression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: Binding of [11C] ABP688 to mGlu5 receptors
timeFrame: Day 1
measure: Blood levels of [11C] ABP688
timeFrame: Day 1, up to 60 minutes
Secondary outcomes:
measure: Difference in [11C]ABP688 binding to mGlu5 receptors
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: