Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058721
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-04-11
Brief Title:
Single Photon Emission Computed Tomography to Study Receptors in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
SPECT Evaluation of Nicotinic Cholinergic Receptors in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2005-01
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 or SPECT see below to examine brain nicotine receptors in evaluating the role of a chemical called acetylcholine in memory and other problems in Parkinsons disease PD Acetylcholine acts by binding to these nicotine receptors
Healthy normal volunteers and patients with Parkinsons disease 40 years of age and older with or without dementia may be eligible for this study Candidates will be screened with physical and neurological examinations a pen and paper test of memory and other mental functions blood tests and for women of childbearing potential a pregnancy test Patients with cognition problems will have more intensive mental function tests
All participants will undergo the following procedures
Magnetic resonance imaging MRI This test uses a strong magnetic field and radio waves to show structural and chemical changes in the brain During the scan the subject lies on a table in a narrow cylinder the scanner The time required in the scanner is about 1 hour during which the subject is asked to lie very still for 10 to 15 minutes at a time He or she can speak with a staff member via an intercom system at all times during the procedure
SPECT This nuclear medicine test produces a picture of the receptors in the brain On the night before the scan the day of the scan and for 4 days after the scan subjects take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure People allergic to potassium iodide will take potassium perchlorate instead Before the scan small radioactive markers containing 99Tc 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 Another catheter is placed in an artery in the wrist to draw arterial blood samples During the scan the subject lies on a bed with his or her head held still with a head holder The scans are taken over a 6-hour period after injection of 123I5-I-A-85380 An electrocardiogram respiration and blood pressure measures are taken before the tracer is injected then 5 minutes after the injection and again 30 to 60 minutes after the injection Blood and urine samples are collected 5 to 6 hours after starting the scan Participants are asked to urinate at least every 2 hours for 12 hours after injection of 123I5-I-A-85380 to decrease radiation exposure
Healthy normal volunteers and patients with Parkinsons disease 40 years of age and older with or without dementia may be eligible for this study Candidates will be screened with physical and neurological examinations a pen and paper test of memory and other mental functions blood tests and for women of childbearing potential a pregnancy test Patients with cognition problems will have more intensive mental function tests
All participants will undergo the following procedures
Magnetic resonance imaging MRI This test uses a strong magnetic field and radio waves to show structural and chemical changes in the brain During the scan the subject lies on a table in a narrow cylinder the scanner The time required in the scanner is about 1 hour during which the subject is asked to lie very still for 10 to 15 minutes at a time He or she can speak with a staff member via an intercom system at all times during the procedure
SPECT This nuclear medicine test produces a picture of the receptors in the brain On the night before the scan the day of the scan and for 4 days after the scan subjects take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure People allergic to potassium iodide will take potassium perchlorate instead Before the scan small radioactive markers containing 99Tc 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 Another catheter is placed in an artery in the wrist to draw arterial blood samples During the scan the subject lies on a bed with his or her head held still with a head holder The scans are taken over a 6-hour period after injection of 123I5-I-A-85380 An electrocardiogram respiration and blood pressure measures are taken before the tracer is injected then 5 minutes after the injection and again 30 to 60 minutes after the injection Blood and urine samples are collected 5 to 6 hours after starting the scan Participants are asked to urinate at least every 2 hours for 12 hours after injection of 123I5-I-A-85380 to decrease radiation exposure
Detailed Description:
Parkinsons disease PD is the second most common neurodegenerative disorder PD is characterized primarily by motor impairment but cognitive impairment is common and dementia may occur in up to 50 of patients Cholinergic deficits have been widely demonstrated in PD patients with and without dementia Cholinergic deficits are more profound in the setting of PD with dementia The cholinergic system mediates aspects of learning and memory and deficits in cholinergic function are correlated with the degree of dementia in PD Additionally the cholinergic system may mediate certain aspects of motor function in PD Data on cholinergic function particularly relating to nicotinic cholinergic receptors are limited to post mortem studies and little is known about the role of the cholinergic system in vivo and how it relates to clinical phenomena The aim of the current study is to assess the feasibility and usefulness of imaging of the high affinity alpha 4 beta 2 nicotinic cholinergic receptor in vivo using SPECT single photon emission computed tomography imaging in patients with PD The long-term goal of the present study is to further understanding of the role of the cholinergic system in the pathogenesis of PD and to elucidate potential diagnostic and therapeutic targets
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-N-0006 | None | None | None |