NCT00096876

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

3.7 years

First QC Date

November 16, 2004

Last Update Submit

April 1, 2019

Conditions

Keywords

Parkinsonian syndrome

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related 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. doi: 10.1002/ana.1049.

    PMID: 11456307BACKGROUND
  • 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.

    PMID: 14593169BACKGROUND
  • 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.

    PMID: 6463130BACKGROUND
  • 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.

    PMID: 7600189BACKGROUND
  • 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.

    PMID: 8559382BACKGROUND
  • 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.

    PMID: 9371905BACKGROUND
  • 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.

    PMID: 10078723BACKGROUND
  • 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.

    PMID: 9527140BACKGROUND
  • 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.

    PMID: 11805242BACKGROUND
  • 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.

    PMID: 3819760BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Danna Jennings, MD

    Institute for Neurodegenerative Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2004

First Posted

November 17, 2004

Study Start

October 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations