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CompletedNCT00096876Updated Apr 3, 2019

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

An observational study in Parkinson Disease and Parkinsonian Syndrome, sponsored by Institute for Neurodegenerative Disorders. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Institute for Neurodegenerative Disorders · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
600
Ages
21 Years and older
Sex
All
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Study summary

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

Read the detailed 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.

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Conditions studied

  • Parkinson Disease
  • Parkinsonian Syndrome

Keywords

  • Parkinsonian syndrome
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 600 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Institute for Neurodegenerative Disorders is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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)
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Study design

Time perspective
Prospective
Enrollment
600 participants (estimated)
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Study locations

1 site
  • Institute for Neurodegenerative Disorders
    New Haven, Connecticut 06510, United States
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References and documents

Publications

  • 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. PubMed 11456307 ↗
  • 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. PubMed 14593169 ↗
  • 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. PubMed 6463130 ↗
  • 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. PubMed 7600189 ↗
  • 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. PubMed 8559382 ↗
  • 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. PubMed 9371905 ↗
  • 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. PubMed 10078723 ↗
  • 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. PubMed 9527140 ↗
  • 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. PubMed 11805242 ↗
  • 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. PubMed 3819760 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00096876
Lead sponsor
Institute for Neurodegenerative Disorders
Responsible party
Sponsor
First posted
Nov 17, 2004
Start date
Oct 2004
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Apr 3, 2019

Study contacts

Danna Jennings, MD
principal investigator · Institute for Neurodegenerative Disorders
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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