A Study of the Sense of Smell in Relatives of Parkinson's Disease Patients

Parkinson Disease Clinical Trial

Official title:

Screening Evaluations for Neurologic Syndromes: Olfactory Testing in Relatives of Parkinson's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096876
• Other study ID #: SENSOR
• Status: Completed
• Start date: October 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2019
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, individuals complete and return a mail survey, specifically a 40 item scratch and sniff smell test.

Description:

This study would extend the findings of previous studies by characterizing the performance of the 40-item UPSIT in a cohort of first-degree relatives of Parkinson's disease (PD) patients. The results would also validate the use of the University of Pennsylvania Smell Identification Test (UPSIT) as a mail-survey instrument. Once identified, these individuals could be followed as a potentially at-risk cohort to determine if the screening evaluation was predictive of later developing Parkinson's disease. The results from this pilot study have the potential to guide the use of olfactory testing using the UPSIT as a screening tool, and to provide necessary preliminary data for planning clinical trials to prevent the occurrence of PD in at-risk individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subject must be a first-degree relative of a PD patient with diagnosis confirmed by a movement disorders specialist at the Institute for Neurodegenerative Disorders

• Subject must not carry a diagnosis of PD or other neurodegenerative disorder

• Subject must be either at least 50 years old or within 10 years of the age of onset of their affected relative

• Subject must be a non-smoker

• Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders

Country where clinical trial is conducted

United States, 

References & Publications (10)

Berendse HW, Booij J, Francot CM, Bergmans PL, Hijman R, Stoof JC, Wolters EC. Subclinical dopaminergic dysfunction in asymptomatic Parkinson's disease patients' relatives with a decreased sense of smell. Ann Neurol. 2001 Jul;50(1):34-41. — View Citation

DeKosky ST, Marek K. Looking backward to move forward: early detection of neurodegenerative disorders. Science. 2003 Oct 31;302(5646):830-4. Review. — View Citation

Doty RL, Bromley SM, Stern MB. Olfactory testing as an aid in the diagnosis of Parkinson's disease: development of optimal discrimination criteria. Neurodegeneration. 1995 Mar;4(1):93-7. — View Citation

Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. — View Citation

Marek KL, Seibyl JP, Zoghbi SS, Zea-Ponce Y, Baldwin RM, Fussell B, Charney DS, van Dyck C, Hoffer PB, Innis RP. [123I] beta-CIT/SPECT imaging demonstrates bilateral loss of dopamine transporters in hemi-Parkinson's disease. Neurology. 1996 Jan;46(1):231-7. — View Citation

Markopoulou K, Larsen KW, Wszolek EK, Denson MA, Lang AE, Pfeiffer RF, Wszolek ZK. Olfactory dysfunction in familial parkinsonism. Neurology. 1997 Nov;49(5):1262-7. — View Citation

Montgomery EB Jr, Baker KB, Lyons K, Koller WC. Abnormal performance on the PD test battery by asymptomatic first-degree relatives. Neurology. 1999 Mar 10;52(4):757-62. — View Citation

Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9. — View Citation

Mouradian MM. Recent advances in the genetics and pathogenesis of Parkinson disease. Neurology. 2002 Jan 22;58(2):179-85. Review. — View Citation

Quinn NP, Rossor MN, Marsden CD. Olfactory threshold in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1987 Jan;50(1):88-9. — View Citation