Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease

NCT00058721 | Completed

• 2 other identifiers: 03000603-N-0006
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 Parkinson's disease (PD). Acetylcholine acts by binding to these nicotine receptors. Healthy normal volunteers and patients with Parkinson's 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 subject's head. Two catheters (thin, flexible tubes) are placed in veins in the arms to inject the radioactive tracer \[123I\]5-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 \[123I\]5-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 \[123I\]5-I-A-85380 to decrease radiation exposure.

Conditions

Parkinson Disease

Keywords

Dementia; Feasibility; Dopamine; Lewy Body; Parkinson Disease; PD; Healthy Volunteer; HV

Interventions

I-123-5-IA85380 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 40.
• Diagnosis of PD.
• Consent.
• Responsible Caregiver (only for patients with dementia).
• Age greater than or equal to 40.
• Consent.

You may not qualify if:

• Secondary cause of Parkinsonism, e.g. Wilson's disease, neuroleptic use.
• Dementia not due to PD, abnormal screening labs for dementia
• Or severe dementia with MMSE less than 15.
• Neurological disorder other than PD that would effect protocol (e.g. stroke, Alzheimer's disease).
• Use of cholinergic or anticholinergic agents within 60 days.
• Abnormal MRI other than mild atrophy.
• Claustrophobia.
• Pregnancy or breast feeding.
• Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
• Any conditions that increase risk for MRI (pacemaker, metallic foreign body, etc.).
• Any medical condition that in the opinion of the investigators would, interfere with the safe conduct of the study.
• Both healthy subjects and patients will be excluded if they have more than moderate hypertension. The subject may be on anti-hypertensive medications. The initial screening must show no more than moderate hypertension- i.e. less than 160/95. On baseline evaluation on the day of the scan (i.e., before injection of tracer), the subject must be asymptomatic (no headache, dizziness, neurological symptoms, or blurred vision) AND have sustained BP less than 180/100.
• History of smoking tobacco, use of nicotine gum or patch or other uses of nicotine within last 5 years.
• Inability to provide consent.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Fujita M, Tamagnan G, Zoghbi SS, Al-Tikriti MS, Baldwin RM, Seibyl JP, Innis RB. Measurement of alpha4beta2 nicotinic acetylcholine receptors with [123I]5-I-A-85380 SPECT. J Nucl Med. 2000 Sep;41(9):1552-60.

  PMID: 10994738 BACKGROUND

• Abreo MA, Lin NH, Garvey DS, Gunn DE, Hettinger AM, Wasicak JT, Pavlik PA, Martin YC, Donnelly-roberts DL, Anderson DJ, Sullivan JP, Williams M, Arneric SP, Holladay MW. Novel 3-Pyridyl ethers with subnanomolar affinity for central neuronal nicotinic acetylcholine receptors. J Med Chem. 1996 Feb 16;39(4):817-25. doi: 10.1021/jm9506884.

  PMID: 8632405 BACKGROUND

• Charpantier E, Barneoud P, Moser P, Besnard F, Sgard F. Nicotinic acetylcholine subunit mRNA expression in dopaminergic neurons of the rat substantia nigra and ventral tegmental area. Neuroreport. 1998 Sep 14;9(13):3097-101. doi: 10.1097/00001756-199809140-00033.

  PMID: 9804323 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 11, 2003
• First Posted: April 11, 2003
• Study Start: April 1, 2003
• Study Completion: January 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-01

Locations

US (1)