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

NCT ID: NCT00096876

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson Disease Parkinsonian Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Neurodegenerative Disorders

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danna Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

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Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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. doi: 10.1002/ana.1049.

Reference Type BACKGROUND
PMID: 11456307 (View on PubMed)

DeKosky ST, Marek K. Looking backward to move forward: early detection of neurodegenerative disorders. Science. 2003 Oct 31;302(5646):830-4. doi: 10.1126/science.1090349.

Reference Type BACKGROUND
PMID: 14593169 (View on PubMed)

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. doi: 10.1016/0031-9384(84)90269-5.

Reference Type BACKGROUND
PMID: 6463130 (View on PubMed)

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. doi: 10.1006/neur.1995.0011.

Reference Type BACKGROUND
PMID: 7600189 (View on PubMed)

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. doi: 10.1212/wnl.46.1.231.

Reference Type BACKGROUND
PMID: 8559382 (View on PubMed)

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. doi: 10.1212/wnl.49.5.1262.

Reference Type BACKGROUND
PMID: 9371905 (View on PubMed)

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. doi: 10.1212/wnl.52.4.757.

Reference Type BACKGROUND
PMID: 10078723 (View on PubMed)

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. doi: 10.1136/jnnp.64.3.314.

Reference Type BACKGROUND
PMID: 9527140 (View on PubMed)

Mouradian MM. Recent advances in the genetics and pathogenesis of Parkinson disease. Neurology. 2002 Jan 22;58(2):179-85. doi: 10.1212/wnl.58.2.179.

Reference Type BACKGROUND
PMID: 11805242 (View on PubMed)

Quinn NP, Rossor MN, Marsden CD. Olfactory threshold in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1987 Jan;50(1):88-9. doi: 10.1136/jnnp.50.1.88.

Reference Type BACKGROUND
PMID: 3819760 (View on PubMed)

Other Identifiers

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SENSOR

Identifier Type: -

Identifier Source: org_study_id

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