Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061789
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-06-04
Brief Title:
Imaging of Brain Receptors in Healthy Volunteers and in Patients With Schizophrenia
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
SPECT Imaging of Alpha 4 Beta 2 Nicotinic Acetylcholine Receptors Using 123I5-I-A-85380 in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use single photon emission computed tomography SPECT to study brain nicotine receptors proteins on the surface of brain cells in healthy subjects and in patients with schizophrenia Autopsy findings in patients with schizophrenia show changes in their nicotine receptors This study will use SPECT to look at these receptors in living schizophrenia patients and compare them with those in healthy subjects
The following individuals between 21 and 50 years of age or between 21 and 80 years of age for Group 1 only are eligible for this study healthy non-smokers Group 1 schizophrenia patients who smoke Group 2 schizophrenia patients who do not smoke Group 3 healthy smokers Group 4 healthy non-smokers Group 5 Patients with schizophrenia must be taking olanzapine Zyprexa or risperidone Risperdal for at least 6 months All candidates will be screened at the first visit Group 1 participants will have three more visits Groups 2 through 5 will have two more visits
Visit 1
All participants will be screened with physical and neurological examinations blood and urine tests and neuropsychological tests to assess their ability to learn and remember words and numbers to pay attention and to quickly perform motor tasks such as putting pegs into a piece of wood In addition they will have an eye movement test and event-related potential testing For the eye test the subject sits in a chair and leans forward with the chin on a chin rest A band is tied around the head and very small amounts of invisible infrared light are shined into the eyes The light is reflected back and measured Wire electrodes are placed around the area of the eye and cheek to monitor eye blinks and eye movements Subjects are asked to follow a light with their eyes and to look away from a light For event- related potential testing electrodes are placed on the scalp forehead and cheeks and brain activity is recorded while the subject identifies particular pictures and sounds
Visit 2 and Visit 3 for Group 1
Participants will have a SPECT scan On the night before the scan the day of the scan and for 4 days after the scan subject take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure Individuals allergic to potassium iodide will take potassium perchlorate instead For the SPECT scan small radioactive markers containing 99mTc are glued to the subjects head Two catheters thin flexible tubes are placed in veins in the arms to inject the radioactive tracer 123I5-I-A-85380 and to draw blood samples During the scan the subject lies on a bed with his or her head held still with a headholder The scans are taken over a 9-hour period after injection of the tracer injection An electrocardiogram respiration and blood pressure measures are taken before injection of 123I5-I-A-85380 then 5 minutes after the injection and again 30 to 60 minutes after the injection Breath samples are collected every 60 minutes Blood and urine samples are collected 5 to 6 hours after starting the scan Group 1 subjects will have a second SPECT scan within 4 weeks of the first
Visit 3 Visit 4 for Group 1
Participants will have a magnetic resonance imaging MRI scan For this procedure the subject lies on a table that slides into a narrow metal cylinder with a strong magnetic field for the scan The scanner uses a magnetic field and radio waves to produce images that show structural and chemical changes in tissues The test lasts up to 1 hour
The following individuals between 21 and 50 years of age or between 21 and 80 years of age for Group 1 only are eligible for this study healthy non-smokers Group 1 schizophrenia patients who smoke Group 2 schizophrenia patients who do not smoke Group 3 healthy smokers Group 4 healthy non-smokers Group 5 Patients with schizophrenia must be taking olanzapine Zyprexa or risperidone Risperdal for at least 6 months All candidates will be screened at the first visit Group 1 participants will have three more visits Groups 2 through 5 will have two more visits
Visit 1
All participants will be screened with physical and neurological examinations blood and urine tests and neuropsychological tests to assess their ability to learn and remember words and numbers to pay attention and to quickly perform motor tasks such as putting pegs into a piece of wood In addition they will have an eye movement test and event-related potential testing For the eye test the subject sits in a chair and leans forward with the chin on a chin rest A band is tied around the head and very small amounts of invisible infrared light are shined into the eyes The light is reflected back and measured Wire electrodes are placed around the area of the eye and cheek to monitor eye blinks and eye movements Subjects are asked to follow a light with their eyes and to look away from a light For event- related potential testing electrodes are placed on the scalp forehead and cheeks and brain activity is recorded while the subject identifies particular pictures and sounds
Visit 2 and Visit 3 for Group 1
Participants will have a SPECT scan On the night before the scan the day of the scan and for 4 days after the scan subject take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure Individuals allergic to potassium iodide will take potassium perchlorate instead For the SPECT scan small radioactive markers containing 99mTc are glued to the subjects head Two catheters thin flexible tubes are placed in veins in the arms to inject the radioactive tracer 123I5-I-A-85380 and to draw blood samples During the scan the subject lies on a bed with his or her head held still with a headholder The scans are taken over a 9-hour period after injection of the tracer injection An electrocardiogram respiration and blood pressure measures are taken before injection of 123I5-I-A-85380 then 5 minutes after the injection and again 30 to 60 minutes after the injection Breath samples are collected every 60 minutes Blood and urine samples are collected 5 to 6 hours after starting the scan Group 1 subjects will have a second SPECT scan within 4 weeks of the first
Visit 3 Visit 4 for Group 1
Participants will have a magnetic resonance imaging MRI scan For this procedure the subject lies on a table that slides into a narrow metal cylinder with a strong magnetic field for the scan The scanner uses a magnetic field and radio waves to produce images that show structural and chemical changes in tissues The test lasts up to 1 hour
Detailed Description:
Abnormalities of nicotinic acetylcholine system in schizophrenia are implied by the high prevalence of cigarette smoking Because animal and human studies have shown that nicotinic acetylcholine receptors nAChRs play an important role in cognitive function cognitive deficits in schizophrenia also suggest abnormalities in these receptors Postmortem studies showed abnormalities in high affinity nAChRs in these patients but the direction of the abnormalities increase or decrease were not consistent probably because it is difficult to control the effects of cigarette smoking and neuroleptics in such studies In vivo imaging studies are necessary to study relationship between nAChRs and psychiatric symptoms including cognitive impairments
We plan to use a new single photon emission computed tomography SPECT tracer 123I5-I-A-85380 which appears suitable for imaging the high affinity Alpha 4 Beta 2 subtype of nAChRs We plan to compare four groups 1 schizophrenia smokers 2 schizophrenia non-smokers 3 healthy smokers and 4 healthy non-smokers All patients will be on stable doses of olanzapine or risperidone In addition to comparing 123I5-I-A-85380 binding among these groups relationship will be studied between psychiatric symptoms or cognitive dysfunction and the SPECT measurement of the receptors Further to study the reliability of the SPECT measurement a test retest study will be preformed in healthy subjects with a wide range The proposed study will explore the roles of nAChRs in the psychiatric symptoms particularly the cognitive deficits in schizophrenia which is the central impairment of this disorder New findings in this research will lead to enhanced treatment of the cognitive deficits
We plan to use a new single photon emission computed tomography SPECT tracer 123I5-I-A-85380 which appears suitable for imaging the high affinity Alpha 4 Beta 2 subtype of nAChRs We plan to compare four groups 1 schizophrenia smokers 2 schizophrenia non-smokers 3 healthy smokers and 4 healthy non-smokers All patients will be on stable doses of olanzapine or risperidone In addition to comparing 123I5-I-A-85380 binding among these groups relationship will be studied between psychiatric symptoms or cognitive dysfunction and the SPECT measurement of the receptors Further to study the reliability of the SPECT measurement a test retest study will be preformed in healthy subjects with a wide range The proposed study will explore the roles of nAChRs in the psychiatric symptoms particularly the cognitive deficits in schizophrenia which is the central impairment of this disorder New findings in this research will lead to enhanced treatment of the cognitive deficits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0003 | None | None | None |