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

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

Official Title
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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)

Conditions
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Depression

Intervention / Treatment
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* Drug: ABP688


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP688<br>Elderly MDD patients and demography matched healthy volunteer | Drug: ABP688<br>* Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABP688, Tracer, Depression